FDA 510(k)

GELFLEX

K-Number: K940848 · 1995-04-07

Decision Date1995-04-07

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

GELFLEX is the device name listed in this FDA 510(k) record. The listed applicant is Venture Management Corp.. It received FDA 510(k) clearance on 1995-04-07 under 510(k) number K940848. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GELFLEX?

GELFLEX is a medical device that received FDA 510(k) clearance on 1995-04-07. The listed applicant is Venture Management Corp.. The 510(k) number is K940848.

When did GELFLEX receive FDA 510(k) clearance?

GELFLEX received FDA 510(k) clearance on 1995-04-07, under 510(k) number K940848.

Who is the listed applicant for GELFLEX?

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

What is the FDA product code for GELFLEX?

The FDA product code for GELFLEX is LPL.

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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.