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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Pump, Infusion
510(k) Number K844078
Device Name PROVIDER PA 3000 INFUSION SYSTEM
Applicant
Pancretec, Inc.
1660 Hotel Cir. N
Suite 630
San Diego,  CA  92108
Applicant Contact RUSSELL HORRES
Correspondent
Pancretec, Inc.
1660 Hotel Cir. N
Suite 630
San Diego,  CA  92108
Correspondent Contact RUSSELL HORRES
Regulation Number880.5725
Classification Product Code
FRN  
Date Received10/19/1984
Decision Date 12/18/1984
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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