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FDA 510(k)

REPHRESH VAGINAL GEL

K-Number: K021737 · 2002-08-26

ApplicantColumbia Laboratories, Inc.
Decision Date2002-08-26
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

REPHRESH VAGINAL GEL is the device name listed in this FDA 510(k) record. The listed applicant is Columbia Laboratories, Inc.. It received FDA 510(k) clearance on 2002-08-26 under 510(k) number K021737. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPHRESH VAGINAL GEL?

REPHRESH VAGINAL GEL is a medical device that received FDA 510(k) clearance on 2002-08-26. The listed applicant is Columbia Laboratories, Inc.. The 510(k) number is K021737.

When did REPHRESH VAGINAL GEL receive FDA 510(k) clearance?

REPHRESH VAGINAL GEL received FDA 510(k) clearance on 2002-08-26, under 510(k) number K021737.

Who is the listed applicant for REPHRESH VAGINAL GEL?

The FDA 510(k) record lists Columbia Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REPHRESH VAGINAL GEL?

The FDA product code for REPHRESH VAGINAL GEL is NUC.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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