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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Aspirating, Bronchoscope, Rigid
510(k) Number K923487
Device Name BAL CATH
Applicant
Ballard Medical Products
12050 Lone Peak Pkwy.
Draper,  UT  84020
Applicant Contact CHAMBERLAIN, JR
Correspondent
Ballard Medical Products
12050 Lone Peak Pkwy.
Draper,  UT  84020
Correspondent Contact CHAMBERLAIN, JR
Regulation Number874.4680
Classification Product Code
KTR  
Date Received07/15/1992
Decision Date 07/30/1993
Decision Substantially Equivalent - Kit (SESK)
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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