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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, Bronchoscope (Non-Rigid)
510(k) Number K102336
Device Name RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS; RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS WITH NE
Applicant
Boston Scientific Corporation
2546 FIRST STREET, PROPARK
ALAJUELA,  CR
Applicant Contact ASHLEY PYLE
Correspondent
Boston Scientific Corporation
2546 FIRST STREET, PROPARK
ALAJUELA,  CR
Correspondent Contact ASHLEY PYLE
Regulation Number874.4680
Classification Product Code
BWH  
Date Received08/18/2010
Decision Date 01/24/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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