GASTRIC, CATHETER, IRRIGATION & ASPIRATION— 510(k) K933596

Name: FDA 510(k) clearance K933596
Creator: U.S. Food and Drug Administration
Published: 1995-02-13

Substantially Equivalent

Polamedco, Inc.

FDA 510(k) clearance K933596 for GASTRIC, CATHETER, IRRIGATION & ASPIRATION, Substantially Equivalent on 1995-02-13. Applicant: Polamedco, Inc.. Device class: 2.

Clearance details

Applicant: Polamedco, Inc.
Product code: Code BSS
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1993-07-26
Decision date: 1995-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Inglewood, CA, US

Download summary PDF View on FDA.gov ↗

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