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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 K925112
Device Name BIO CLINIC UNDER PATIENT SCALE
Applicant
Sunrise Medical, Inc.
4083 E. Airport Dr.
Ontario,  CA  91761
Applicant Contact KEITH GILROY
Correspondent
Sunrise Medical, Inc.
4083 E. Airport Dr.
Ontario,  CA  91761
Correspondent Contact KEITH GILROY
Regulation Number880.5725
Classification Product Code
FRN  
Date Received10/09/1992
Decision Date 06/18/1993
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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