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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
510(k) Number K973472
Device Name 3M CDI H/S CUVETTES WITH HEPARON TREATMENT
Applicant
3M Healthcare
1311 Valencia Ave.
Tistin,  CA  92780
Applicant Contact DIANA RHEA
Correspondent
3M Healthcare
1311 Valencia Ave.
Tistin,  CA  92780
Correspondent Contact DIANA RHEA
Regulation Number870.4330
Classification Product Code
DRY  
Date Received09/12/1997
Decision Date 12/08/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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