AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027

FDA 510(k) Premarket Notification · Submission K092086 · Applicant: Amerx Health Care Corp.

Public Record 510(k) Submission Decision Date: 2009-07-30 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K092086.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K092086

Applicant / Sponsor

Amerx Health Care Corp.

Device Name

AMERIGEL WOUND DRESSING PLUS 1/2 OZ. (15G TUBE), MODEL A2025; 1 OZ. (30G TUBE), MODEL A2026; 3 OZ (90G TUBE),MODEL A2027

Product Code

SEJ

Decision Date

2009-07-30

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Unknown ()

Clearance Type

Traditional

Third Party Flag

Date Received

2009-07-09

Related Establishments / Registrations

MPM MEDICAL Registration: 1646434 View Registration
Strukmyer Medical Registration: 1648579 View Registration
BIOMED LABORATORIES LLC Registration: 3006784948 View Registration

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This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.