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FDA 510(k)

DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10)

K-Number: K962439 · 1996-09-03

ApplicantRichard Hamer Assoc., Inc.
Decision Date1996-09-03
Product CodeMGQ
DecisionSubstantially Equivalent

Device Summary

DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10) is the device name listed in this FDA 510(k) record. The listed applicant is Richard Hamer Assoc., Inc.. It received FDA 510(k) clearance on 1996-09-03 under 510(k) number K962439. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10)?

DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10) is a medical device that received FDA 510(k) clearance on 1996-09-03. The listed applicant is Richard Hamer Assoc., Inc.. The 510(k) number is K962439.

When did DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10) receive FDA 510(k) clearance?

DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10) received FDA 510(k) clearance on 1996-09-03, under 510(k) number K962439.

Who is the listed applicant for DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10)?

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

What is the FDA product code for DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10)?

The FDA product code for DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10) is MGQ.

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Other records listing Richard Hamer Assoc., 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.

K951325COMFEEL PLUS PRESSURE RELIEF DRESSINGK950934MPM HYDROGEL DRESSINGK951327COMFEEL PLUS CONTOUR DRESSINGK942283COMFEEL PLUS TRANSPARENT DRESSINGK942573COSTELLO-EVERETT LASER CYSTOSCOPE SHEATHK941263COMFEEL PLUS WOUND DRESSING

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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

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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