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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Autotransfusion
510(k) Number K902713
Device Name ACCESS. KIT FOR THE BIOSURGE SYNCHRONOUS AUTOTRANS
Applicant
DIEMOLDING CORP.
125 RASBACH ST.
CANASTOTA,  NY  13032
Applicant Contact JEAN WALLACE
Correspondent
DIEMOLDING CORP.
125 RASBACH ST.
CANASTOTA,  NY  13032
Correspondent Contact JEAN WALLACE
Regulation Number868.5830
Classification Product Code
CAC  
Date Received06/20/1990
Decision Date 07/25/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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