SYNTEC, INC. DISPOSABLE BARE END FIBER— 510(k) K971338

Name: FDA 510(k) clearance K971338
Creator: U.S. Food and Drug Administration
Published: 1997-05-06

Substantially Equivalent

Syntec, Inc.

FDA 510(k) clearance K971338 for SYNTEC, INC. DISPOSABLE BARE END FIBER, Substantially Equivalent on 1997-05-06. Applicant: Syntec, Inc.. Device class: 2.

Clearance details

Applicant: Syntec, Inc.
Product code: Code MPA
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1997-04-10
Decision date: 1997-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crystal City, MO, US

Download summary PDF View on FDA.gov ↗

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