DEVINE (SUPRAPUBIC SOUND AND GUIDE)— 510(k) K873177

Name: FDA 510(k) clearance K873177
Creator: U.S. Food and Drug Administration
Published: 1987-10-14

Substantially Equivalent

Penn Medical Devices, Inc.

FDA 510(k) clearance K873177 for DEVINE (SUPRAPUBIC SOUND AND GUIDE), Substantially Equivalent on 1987-10-14. Applicant: Penn Medical Devices, Inc.. Device class: 2.

Clearance details

Applicant: Penn Medical Devices, Inc.
Product code: Code KOE
Device class: Class 2
Regulation: 21 CFR 876.5520
Advisory panel: Gastroenterology, Urology
Date received: 1987-08-12
Decision date: 1987-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Basking Ridge, NJ, US

Download summary PDF View on FDA.gov ↗

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