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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K896146
Device Name BIOPSY FORCEPS, (NON-RIGID)
Applicant
Portlyn Corp.
Rfd #1 Box 451, Rte. 25
Moultonboro,  NH  03254
Applicant Contact JOSEPH SKORUPA
Correspondent
Portlyn Corp.
Rfd #1 Box 451, Rte. 25
Moultonboro,  NH  03254
Correspondent Contact JOSEPH SKORUPA
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received10/23/1989
Decision Date 03/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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