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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 K843463
Device Name PROVIDER BAG SPIKE W/12 MICROBORE EXTEN
Applicant
PANCRETEC, INC.
1660 HOTEL CIRCLE N
SUITE 630
SAN DIEGO,  CA  92108
Applicant Contact RUSSELL HORRES
Correspondent
PANCRETEC, INC.
1660 HOTEL CIRCLE N
SUITE 630
SAN DIEGO,  CA  92108
Correspondent Contact RUSSELL HORRES
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/05/1984
Decision Date 10/11/1984
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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