SCHUSTER DISPOSABLE BALLOON PROBE— 510(k) K931175

Name: FDA 510(k) clearance K931175
Creator: U.S. Food and Drug Administration
Published: 1994-04-01

Substantially Equivalent

Sandhill Scientific, Inc.

FDA 510(k) clearance K931175 for SCHUSTER DISPOSABLE BALLOON PROBE, Substantially Equivalent on 1994-04-01. Applicant: Sandhill Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Sandhill Scientific, Inc.
Product code: Code FAP
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 1993-03-09
Decision date: 1994-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, CO, US

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