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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 K852178
Device Name EXU-BAG CSU-1200(DISPOS)CANISTER 602-2(NON-DISPOS
Applicant
American Omni Medical, Inc.
2930-G Grace Ln.
Costa Mesa,  CA  92626
Applicant Contact GEORGE G SIPOSS
Correspondent
American Omni Medical, Inc.
2930-G Grace Ln.
Costa Mesa,  CA  92626
Correspondent Contact GEORGE G SIPOSS
Regulation Number868.5830
Classification Product Code
CAC  
Date Received05/20/1985
Decision Date 12/27/1985
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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