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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Biopsy, Endomyocardial
510(k) Number K951447
Device Name DYNABITE CARDIOVASCULAR 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 Number870.4075
Classification Product Code
DWZ  
Date Received03/29/1995
Decision Date 07/27/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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