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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instruments, Surgical, Cardiovascular
510(k) Number K881392
Device Name CARDICAD(TM)
Applicant
Medical/Surgical Specialties, Ltd.
1611 W. Centre St.
Kalamazoo,  MI  49002
Applicant Contact JAMES L PHILLIPS
Correspondent
Medical/Surgical Specialties, Ltd.
1611 W. Centre St.
Kalamazoo,  MI  49002
Correspondent Contact JAMES L PHILLIPS
Regulation Number870.4500
Classification Product Code
DWS  
Date Received04/04/1988
Decision Date 05/31/1988
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
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