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FDA 510(k)

AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES

K-Number: K972646 · 1997-08-21

ApplicantLudlow Technical Products
Decision Date1997-08-21
Product CodeNAE
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES is the device name listed in this FDA 510(k) record. The listed applicant is Ludlow Technical Products. It received FDA 510(k) clearance on 1997-08-21 under 510(k) number K972646. 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 AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES?

AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES is a medical device that received FDA 510(k) clearance on 1997-08-21. The listed applicant is Ludlow Technical Products. The 510(k) number is K972646.

When did AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES receive FDA 510(k) clearance?

AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES received FDA 510(k) clearance on 1997-08-21, under 510(k) number K972646.

Who is the listed applicant for AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES?

The FDA 510(k) record lists Ludlow Technical Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES?

The FDA product code for AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES is NAE.

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Other records listing Ludlow Technical Products 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.

K991235SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP IUPC)K973110LUDLOW TECHNICAL PRODUCTS, ELECTRODE, ELECTROSURGICAL, DISPOSABLE PEDIATRIC DISPERSIVE ELECTRODES; WITH AND WITHOUT CORDK964401KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4)K931903SURELOCK(TM) SNAPLESS MONITORING ELECTRODE

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.K971597COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)Coloplast Corp.

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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