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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
Recalls CDRH Recalls
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