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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K822776
Device Name TEFLON CANNULA
Applicant
CARDIAC PACEMAKERS, INC.
MN 
Correspondent
CARDIAC PACEMAKERS, INC.
MN 
Regulation Number880.5200
Classification Product Code
FOZ  
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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