SILICONE RECTAL BALLOON— 510(k) K930135

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K930135 for SILICONE RECTAL BALLOON, Substantially Equivalent on 1993-10-08. Applicant: Cook Urological, Inc.. Device class: 2.

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code FEN
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1993-01-12
Decision date: 1993-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

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