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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 K850729
Device Name ACUFLO VOLUMETRIC CONTROLLED DELIVERY SYS 2000
Applicant
Surgidev Corp.
5743 Thornwood Dr.
Goleta,  CA  93117
Applicant Contact MICHAEL E PFLEGER
Correspondent
Surgidev Corp.
5743 Thornwood Dr.
Goleta,  CA  93117
Correspondent Contact MICHAEL E PFLEGER
Regulation Number880.5725
Classification Product Code
FRN  
Date Received02/22/1985
Decision Date 04/09/1985
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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