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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K822775
Device Name INFUS. SETS-9120-50 CM & 9121-100 CM,EXT
Applicant
Cardiac Pacemakers, Inc.
MN 
Correspondent
Cardiac Pacemakers, Inc.
MN 
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/14/1982
Decision Date 11/03/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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