DISPOSABLE IRRIGA/ASPIR. SYSTEM— 510(k) K821496

Name: FDA 510(k) clearance K821496
Creator: U.S. Food and Drug Administration
Published: 1982-06-22

Substantially Equivalent

Innovative Surgical Products, Inc.

FDA 510(k) clearance K821496 for DISPOSABLE IRRIGA/ASPIR. SYSTEM, Substantially Equivalent on 1982-06-22. Applicant: Innovative Surgical Products, Inc.. Device class: 2.

Clearance details

Applicant: Innovative Surgical Products, Inc.
Product code: Code KDH
Device class: Class 2
Regulation: 21 CFR 876.5980
Advisory panel: Gastroenterology, Urology
Date received: 1982-05-19
Decision date: 1982-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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