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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K010649
Device Name EXHALE DOPPLER SYSTEM
Applicant
Broncus Technologies, Inc.
1400 N. Shoreline Blvd., Bldg. A, Suite 8
Mountain View,  CA  94043
Applicant Contact TIMOTHY R WILLIAMS
Correspondent
Tuv Product Service, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Correspondent Contact MARK JOB
Regulation Number892.1550
Classification Product Code
IYN  
Date Received03/05/2001
Decision Date 03/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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