DISPOSABLE, STERILE BIOPSY PUNCH— 510(k) K853104

Name: FDA 510(k) clearance K853104
Creator: U.S. Food and Drug Administration
Published: 1985-10-04

Substantially Equivalent

August C. Stiefel Research Institute, Inc.

FDA 510(k) clearance K853104 for DISPOSABLE, STERILE BIOPSY PUNCH, Substantially Equivalent on 1985-10-04. Applicant: August C. Stiefel Research Institute, Inc.. Device class: 2.

Clearance details

Applicant: August C. Stiefel Research Institute, Inc.
Product code: Code FCI
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1985-07-23
Decision date: 1985-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakhill, NY, US

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