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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, Non-Electric
510(k) Number K896147
Device Name BIOPSY FORCEP (NON-ELECTRIC)
Applicant
PORTLYN CORP.
RFD 1, BOX 451
ROUTE 25
MOULTONBORO,  NH  03254
Applicant Contact JOSEPH SKORUPA
Correspondent
PORTLYN CORP.
RFD 1, BOX 451
ROUTE 25
MOULTONBORO,  NH  03254
Correspondent Contact JOSEPH SKORUPA
Regulation Number876.1075
Classification Product Code
FCL  
Date Received10/23/1989
Decision Date 04/16/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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