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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 K022398
Device Name REUSABLE BRONCHIAL BIOPSY FORCEPS
Applicant
Ballard Medical Products
12050 Lone Peak Pkwy.
Draper,  UT  84020
Applicant Contact CINDY ELLIS
Correspondent
Ballard Medical Products
12050 Lone Peak Pkwy.
Draper,  UT  84020
Correspondent Contact CINDY ELLIS
Regulation Number874.4680
Classification Product Code
BWH  
Date Received07/23/2002
Decision Date 10/11/2002
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
Predetermined Change
Control Plan Authorized		 No
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