COOK LAPAROSCOPIC MINI RETRACTOR SET— 510(k) K936026

Name: FDA 510(k) clearance K936026
Creator: U.S. Food and Drug Administration
Published: 1994-03-11

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K936026 for COOK LAPAROSCOPIC MINI RETRACTOR SET, Substantially Equivalent on 1994-03-11. Applicant: Cook Urological, Inc.. Device class: 2.

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code HFI
Device class: Class 2
Regulation: 21 CFR 884.4160
Advisory panel: Obstetrics/Gynecology
Date received: 1993-12-17
Decision date: 1994-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, US

Download summary PDF View on FDA.gov ↗

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