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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 K861725
Device Name INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT
Applicant
PARKE-DAVIS CO.
870 PARKDALE RD.
ROCHESTER,  MI  48307
Applicant Contact CLEARY
Correspondent
PARKE-DAVIS CO.
870 PARKDALE RD.
ROCHESTER,  MI  48307
Correspondent Contact CLEARY
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received05/06/1986
Decision Date 12/04/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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