DYNABITE HOT GI BIOPSY FORCEPS— 510(k) K970083

Substantially Equivalent

Portlyn Corp.

FDA 510(k) clearance K970083 for DYNABITE HOT GI BIOPSY FORCEPS, Substantially Equivalent on 1997-06-17. Applicant: Portlyn Corp.. Device class: 2.

Clearance details

Applicant
Portlyn Corp.
Product code
Code KGE
Device class
Class 2
Regulation
21 CFR 876.4300
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Moultonboro, NH, US
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