GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE— 510(k) K990584

Name: FDA 510(k) clearance K990584
Creator: U.S. Food and Drug Administration
Published: 1999-04-23

Substantially Equivalent

Broadline Medical Industries

FDA 510(k) clearance K990584 for GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE, Substantially Equivalent on 1999-04-23. Applicant: Broadline Medical Industries. Device class: Unclassified.

Clearance details

Applicant: Broadline Medical Industries
Product code: Code EFQ
Device class: Unclassified
Advisory panel: Unknown
Date received: 1999-02-23
Decision date: 1999-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Inverness, IL, US

Download summary PDF View on FDA.gov ↗

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