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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 K023083
Device Name SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800
Applicant
Mettler Electronics Corp.
1333 S. Claudina St.
Anaheim,  CA  92805
Applicant Contact ROBERT E FLEMING
Correspondent
Mettler Electronics Corp.
1333 S. Claudina St.
Anaheim,  CA  92805
Correspondent Contact ROBERT E FLEMING
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Code
IMG  
Date Received09/17/2002
Decision Date 02/28/2003
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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