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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 K936220
Device Name DIDECO VACUUM PUMP
Applicant
Dideco
Via Statale 12 Nord, 86
Mirandola ( Modena),  IT 41037
Applicant Contact ROSINA ROBINSON, R.N
Correspondent
Dideco
Via Statale 12 Nord, 86
Mirandola ( Modena),  IT 41037
Correspondent Contact ROSINA ROBINSON, R.N
Regulation Number868.5830
Classification Product Code
CAC  
Date Received12/28/1993
Decision Date 01/27/1995
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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