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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 K952391
Device Name DYNABITE UROLOGICAL FORCEPS
Applicant
PORTLYN CORP.
ROUTE 25
MOULTONBORO,  NH  03254
Applicant Contact GEORGE A LYNA
Correspondent
PORTLYN CORP.
ROUTE 25
MOULTONBORO,  NH  03254
Correspondent Contact GEORGE A LYNA
Regulation Number876.1075
Classification Product Code
FCL  
Date Received05/22/1995
Decision Date 06/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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