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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
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 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
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