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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Biopsy, Electric
510(k) Number K970083
Device Name DYNABITE HOT GI BIOPSY FORCEPS
Applicant
Portlyn Corp.
Rfd #1 Box 451, Rte. 25
Moultonboro,  NH  03254
Applicant Contact GEORGE A LYNA
Correspondent
Portlyn Corp.
Rfd #1 Box 451, Rte. 25
Moultonboro,  NH  03254
Correspondent Contact GEORGE A LYNA
Regulation Number876.4300
Classification Product Code
KGE  
Date Received01/09/1997
Decision Date 06/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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