FDA 510(k)

WOUND HYDROGEL & STERILE WOUND HYDROGEL

K-Number: K961766 · 1996-07-15

ApplicantRenaissance Pharmaceutical, Inc.

Decision Date1996-07-15

Product CodeMGQ

DecisionSubstantially Equivalent for Some Indications

Device Summary

WOUND HYDROGEL & STERILE WOUND HYDROGEL is the device name listed in this FDA 510(k) record. The listed applicant is Renaissance Pharmaceutical, Inc.. It received FDA 510(k) clearance on 1996-07-15 under 510(k) number K961766. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the WOUND HYDROGEL & STERILE WOUND HYDROGEL?

WOUND HYDROGEL & STERILE WOUND HYDROGEL is a medical device that received FDA 510(k) clearance on 1996-07-15. The listed applicant is Renaissance Pharmaceutical, Inc.. The 510(k) number is K961766.

When did WOUND HYDROGEL & STERILE WOUND HYDROGEL receive FDA 510(k) clearance?

WOUND HYDROGEL & STERILE WOUND HYDROGEL received FDA 510(k) clearance on 1996-07-15, under 510(k) number K961766.

Who is the listed applicant for WOUND HYDROGEL & STERILE WOUND HYDROGEL?

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

What is the FDA product code for WOUND HYDROGEL & STERILE WOUND HYDROGEL?

The FDA product code for WOUND HYDROGEL & STERILE WOUND HYDROGEL is MGQ.

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Other records listing Renaissance Pharmaceutical, Inc. as applicant

K961316WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL K954384WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL K941339STERILE WOUND HYDROGEL DRESSING

Related Devices (Code: MGQ)

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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.