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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 K990101
Device Name PAIN CONTROL INFUSION PUMP
Applicant
Sgarlato Laboratories, Inc.
250 Almendra Ave.
Los Gatos,  CA  95030
Applicant Contact THOMAS SGARLATO
Correspondent
Sgarlato Laboratories, Inc.
250 Almendra Ave.
Los Gatos,  CA  95030
Correspondent Contact THOMAS SGARLATO
Regulation Number880.5725
Classification Product Code
FRN  
Date Received01/12/1999
Decision Date 03/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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