MODIFICATION'S TO TORAY'S B-2 SERIES— 510(k) K863297

Name: FDA 510(k) clearance K863297
Creator: U.S. Food and Drug Administration
Published: 1986-09-25

Substantially Equivalent

National Medical Care, Medical Products Div., Inc.

FDA 510(k) clearance K863297 for MODIFICATION'S TO TORAY'S B-2 SERIES, Substantially Equivalent on 1986-09-25. Applicant: National Medical Care, Medical Products Div., Inc.. Device class: 2.

Clearance details

Applicant: National Medical Care, Medical Products Div., Inc.
Product code: Code FJT
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1986-08-25
Decision date: 1986-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockleigh, NJ, US

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