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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Electric For Gravity Flow Infusion Systems
510(k) Number K902808
Device Name DRIPTROL
Applicant
Trans-Pacific Healthcare-USA
132 Edgemere Way S.
Naples,  FL  33999
Applicant Contact JOSEPH KASKIE
Correspondent
Trans-Pacific Healthcare-USA
132 Edgemere Way S.
Naples,  FL  33999
Correspondent Contact JOSEPH KASKIE
Regulation Number880.2420
Classification Product Code
FLN  
Date Received06/27/1990
Decision Date 10/01/1990
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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