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FDA 510(k)

GELIPERM TRANSPARENT GEL-FILM DRESSING

K-Number: K822058 · 1983-08-12

ApplicantHamel, Park, Mccabe & Saunders
Decision Date1983-08-12
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

GELIPERM TRANSPARENT GEL-FILM DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Hamel, Park, Mccabe & Saunders. It received FDA 510(k) clearance on 1983-08-12 under 510(k) number K822058. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GELIPERM TRANSPARENT GEL-FILM DRESSING?

GELIPERM TRANSPARENT GEL-FILM DRESSING is a medical device that received FDA 510(k) clearance on 1983-08-12. The listed applicant is Hamel, Park, Mccabe & Saunders. The 510(k) number is K822058.

When did GELIPERM TRANSPARENT GEL-FILM DRESSING receive FDA 510(k) clearance?

GELIPERM TRANSPARENT GEL-FILM DRESSING received FDA 510(k) clearance on 1983-08-12, under 510(k) number K822058.

Who is the listed applicant for GELIPERM TRANSPARENT GEL-FILM DRESSING?

The FDA 510(k) record lists Hamel, Park, Mccabe & Saunders as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GELIPERM TRANSPARENT GEL-FILM DRESSING?

The FDA product code for GELIPERM TRANSPARENT GEL-FILM DRESSING is FRO. This falls under the Anesthesiology category.

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Other records listing Hamel, Park, Mccabe & Saunders 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.

K822073GELIPERM DRYK822315GFB-B CONTACT LENS BLANKS

Related Devices (Code: FRO)

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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, 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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