TRANSDUCER PROTECTOR— 510(k) K910821

Substantially Equivalent

Gelman Sciences, Inc.

FDA 510(k) clearance K910821 for TRANSDUCER PROTECTOR, Substantially Equivalent on 1991-08-12. Applicant: Gelman Sciences, Inc.. Device class: 2.

Clearance details

Applicant
Gelman Sciences, Inc.
Product code
Code FIB
Device class
Class 2
Regulation
21 CFR 876.5820
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ann Arbor, MI, US
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