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FDA 510(k)

WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL

K-Number: K954384 · 1995-10-16

ApplicantRenaissance Pharmaceutical, Inc.
Decision Date1995-10-16
Product CodeMGQ
DecisionSubstantially Equivalent for Some Indications

Device Summary

WOUND HYDROGEL AND/OR 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 1995-10-16 under 510(k) number K954384. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL?

WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL is a medical device that received FDA 510(k) clearance on 1995-10-16. The listed applicant is Renaissance Pharmaceutical, Inc.. The 510(k) number is K954384.

When did WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL receive FDA 510(k) clearance?

WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL received FDA 510(k) clearance on 1995-10-16, under 510(k) number K954384.

Who is the listed applicant for WOUND HYDROGEL AND/OR 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 AND/OR STERILE WOUND HYDROGEL?

The FDA product code for WOUND HYDROGEL AND/OR STERILE WOUND HYDROGEL is MGQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Renaissance Pharmaceutical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K961316WOUND HYDROGEL AND/OR STERILE WOUND HYDROGELK961766WOUND HYDROGEL & STERILE WOUND HYDROGELK941339STERILE WOUND HYDROGEL DRESSING

Related Devices (Code: MGQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171879HylaGuard Moisturizing CreamFounders Science Group, LLCK083024HYLATOPIC EMOLLIENT FOAMCollegium Pharmaceutical IncorporatedK041342IMPRUV A.I. CREAM WOUND AND SKIN EMULSIONStiefel Laboratories, Inc.K041268SILVERSITE OR CALGITROLAdriK040019SILVERSEALNoble Fiber TechnologiesK040517TENDERWET ACTIVEMedline Industries, Inc.

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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