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FDA 510(k)

HYDROGEL SKIN DRESSING

K-Number: K962352 · 1996-08-02

ApplicantNorth American Sterilization & Packaging Co.
Decision Date1996-08-02
Product CodeNAE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HYDROGEL SKIN DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is North American Sterilization & Packaging Co.. It received FDA 510(k) clearance on 1996-08-02 under 510(k) number K962352. 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 HYDROGEL SKIN DRESSING?

HYDROGEL SKIN DRESSING is a medical device that received FDA 510(k) clearance on 1996-08-02. The listed applicant is North American Sterilization & Packaging Co.. The 510(k) number is K962352.

When did HYDROGEL SKIN DRESSING receive FDA 510(k) clearance?

HYDROGEL SKIN DRESSING received FDA 510(k) clearance on 1996-08-02, under 510(k) number K962352.

Who is the listed applicant for HYDROGEL SKIN DRESSING?

The FDA 510(k) record lists North American Sterilization & Packaging Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYDROGEL SKIN DRESSING?

The FDA product code for HYDROGEL SKIN DRESSING is NAE.

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Other records listing North American Sterilization & Packaging Co. 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.

K964231NASP HYDROCOLLOID DRESSING (REGULAR OR THIN)K963753NASP TRANSPARENT DRESSINGK925588NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRIK925593NORTEC STERILE WATER FOR DEVICE IRRIGATIONK925161NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIOK911865NORTEC CONNECTING TUBE SET

View all 16 devices →

Related Devices (Code: NAE)

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.

K083721MODIFICATION TO ZENIEVARiver'S Edge Pharmaceuticals, LLCK082865MODIFICATION TO ZENIEVAGorbec Pharmaceutical Services, Inc.K073246ZENIEVAGorbec Pharmaceutical Services, Inc.K992094GILTECH PLUS HYDROGEL SKIN DRESSINGGiltech Plus, Inc.K991061DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSINGDermaphylyx, Inc.K972646AD-HEAL HYDROGEL DRESSING, VARIOUS SIZESLudlow Technical Products

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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