MODEL TX-8 PANENDOSCOPE— 510(k) K760822

Name: FDA 510(k) clearance K760822
Creator: U.S. Food and Drug Administration
Published: 1976-10-21

Substantially Equivalent

American Cystocope Makers, Inc.

FDA 510(k) clearance K760822 for MODEL TX-8 PANENDOSCOPE, Substantially Equivalent on 1976-10-21. Applicant: American Cystocope Makers, Inc.. Device class: 2.

Clearance details

Applicant: American Cystocope Makers, Inc.
Product code: Code FAK
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1976-10-13
Decision date: 1976-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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