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FDA 510(k)

AMERIGEL OINTMENT

K-Number: K970133 · 1997-04-14

ApplicantAmerx Health Care Corp.
Decision Date1997-04-14
Product CodeMGQ
DecisionSubstantially Equivalent for Some Indications

Device Summary

AMERIGEL OINTMENT is the device name listed in this FDA 510(k) record. The listed applicant is Amerx Health Care Corp.. It received FDA 510(k) clearance on 1997-04-14 under 510(k) number K970133. The device is classified under product code MGQ. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the AMERIGEL OINTMENT?

AMERIGEL OINTMENT is a medical device that received FDA 510(k) clearance on 1997-04-14. The listed applicant is Amerx Health Care Corp.. The 510(k) number is K970133.

When did AMERIGEL OINTMENT receive FDA 510(k) clearance?

AMERIGEL OINTMENT received FDA 510(k) clearance on 1997-04-14, under 510(k) number K970133.

Who is the listed applicant for AMERIGEL OINTMENT?

The FDA 510(k) record lists Amerx Health Care Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMERIGEL OINTMENT?

The FDA product code for AMERIGEL OINTMENT 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 Amerx Health Care Corp. 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.

K092086AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027K971918AMERIGEL OINTMENT SATURATED WOUND 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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