P-S MEDICAL BERLIN VISADUCT KIT— 510(k) K832677

Name: FDA 510(k) clearance K832677
Creator: U.S. Food and Drug Administration
Published: 1983-12-08

Substantially Equivalent

Pudenz-Schulte Medical Research Corp.

FDA 510(k) clearance K832677 for P-S MEDICAL BERLIN VISADUCT KIT, Substantially Equivalent on 1983-12-08. Applicant: Pudenz-Schulte Medical Research Corp.. Device class: 1.

Clearance details

Applicant: Pudenz-Schulte Medical Research Corp.
Product code: Code KOA
Device class: Class 1
Regulation: 21 CFR 876.4730
Advisory panel: Gastroenterology, Urology
Date received: 1983-08-09
Decision date: 1983-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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