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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Exhaust, Surgical
510(k) Number K914118
Device Name I.C. MEDICAL AUTO INTRA-ABDOMINAL PLUME ELIMINATOR
Applicant
I.C Medical, Inc.
2340 W. Shangri La
Suite 202
Phoenix,  AZ  85029
Applicant Contact LOAN COSMESCU
Correspondent
I.C Medical, Inc.
2340 W. Shangri La
Suite 202
Phoenix,  AZ  85029
Correspondent Contact LOAN COSMESCU
Regulation Number878.5070
Classification Product Code
FYD  
Date Received09/13/1991
Decision Date 02/12/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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