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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 K091250
Device Name DIAGNOSTIC CATHETER SYSTEM
Applicant
CARDINAL HEALTH, INC.
1430 WAUKEGAN ROAD- MPKB-3B
MCGAW PARK,  IL  60085
Applicant Contact SHARON NICHOLS
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact NED DEVINE
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received04/28/2009
Decision Date 05/22/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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