GAUZE SPONGES, INTERNAL AND EXTERNAL— 510(k) K905136

Name: FDA 510(k) clearance K905136
Creator: U.S. Food and Drug Administration
Published: 1991-03-06

Substantially Equivalent

American Healthcare Corp.

FDA 510(k) clearance K905136 for GAUZE SPONGES, INTERNAL AND EXTERNAL, Substantially Equivalent on 1991-03-06. Applicant: American Healthcare Corp.. Device class: Unclassified.

Clearance details

Applicant: American Healthcare Corp.
Product code: Code EFQ
Device class: Unclassified
Advisory panel: Unknown
Date received: 1990-11-15
Decision date: 1991-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada, CA

Download summary PDF View on FDA.gov ↗

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K991757 — NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE1999-08-12
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K990974 — VITOP DRESSING1999-06-09
K990584 — GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE1999-04-23
K984187 — CROSSTEX NON-WOVEN SPONGES1999-02-18

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K923939 — IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER1993-06-17
K923940 — IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE1993-06-17
K923941 — IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE1993-06-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.