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Briarcliff767
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I am importer from other countries. I have a question about

Customer Question

Hi..
I am importer from other countries.
I have a question about the products for PH balanced gel for vaginal odor,vaginal PH...
I need a FDA approval?
Daniel Jung (###) ###-####***@******.***
Thank You
Submitted: 1 year ago.
Category: Legal
Expert:  Briarcliff767 replied 1 year ago.

Hi my name is ***** ***** I am happy to assist you. Are you asking if you need FDA approval as an importer or what exactly is your request? Do you have the products made in a different country then you purchase that product sndcsake under your company?

Customer: replied 1 year ago.

not for company...need a FDA approval about the product?

we want to import similar one below...


RepHresh Vaginal Gel,, 0.07 oz., 4 Prefilled Applicators

About the Product





  • Maintains healthy vaginal pH

  • Eliminates the cause of odor, itching, and irritation

  • Estrogen Free




Customer: replied 1 year ago.

not for company...need a FDA approval about the product?

we want to import similar one below...


RepHresh Vaginal Gel,, 0.07 oz., 4 Prefilled Applicators

About the Product





  • Maintains healthy vaginal pH

  • Eliminates the cause of odor, itching, and irritation

  • Estrogen Free


Daniel Jung


(###) ###-####/p>


Expert:  Briarcliff767 replied 1 year ago.

Hi yes you will need to do a Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. You can see how to do that by clicking this link here if you need my help with this please let me know

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm

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