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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 K121186
Device Name RADIAL JAW 4 PULMONARY BIOPSY FORCEPS
Applicant
Boston Scientific Corp
100 Boston Scientific Way
Marlboro,  MA  01752
Applicant Contact CORRIE GOODING
Correspondent
Boston Scientific Corp
100 Boston Scientific Way
Marlboro,  MA  01752
Correspondent Contact CORRIE GOODING
Regulation Number874.4680
Classification Product Code
BWH  
Date Received04/18/2012
Decision Date 05/16/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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