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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cpb Check Valve, Retrograde Flow, In-Line
510(k) Number K001245
Device Name 3T L. V. CONTROL VALVE
Applicant
3T MEDICAL SYSTEMS, LLC.
6770 PINE WAY DR.
TROY,  MI  48098
Applicant Contact TIMOTHY J SIMMONS
Correspondent
3T MEDICAL SYSTEMS, LLC.
6770 PINE WAY DR.
TROY,  MI  48098
Correspondent Contact TIMOTHY J SIMMONS
Regulation Number870.4400
Classification Product Code
MJJ  
Date Received04/18/2000
Decision Date 08/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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