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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 K870866
Device Name THE GRIPPER(TM) PORT-A-CATH NEEDLES
Applicant
Pharmacia, Inc.
800 Centennial Ave.
Piscataway,  NJ  08854 -3911
Applicant Contact ALBERT P MAYO
Correspondent
Pharmacia, Inc.
800 Centennial Ave.
Piscataway,  NJ  08854 -3911
Correspondent Contact ALBERT P MAYO
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
FMI  
Date Received03/03/1987
Decision Date 06/25/1987
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
Recalls CDRH Recalls
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