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FDA 510(k)

COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)

K-Number: K971597 · 1997-07-29

ApplicantColoplast Corp.
Decision Date1997-07-29
Product CodeNAE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 1997-07-29 under 510(k) number K971597. The device is classified under product code NAE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)?

COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) is a medical device that received FDA 510(k) clearance on 1997-07-29. The listed applicant is Coloplast Corp.. The 510(k) number is K971597.

When did COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) receive FDA 510(k) clearance?

COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) received FDA 510(k) clearance on 1997-07-29, under 510(k) number K971597.

Who is the listed applicant for COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)?

The FDA 510(k) record lists Coloplast Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)?

The FDA product code for COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) is NAE.

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Official Source

View on FDA Database →

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

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