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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K954287
Device Name ACI FINE NEEDLE ASPIRATION BIOPSY KIT
Applicant
ADVANCED CYTOMETRIX, INC.
995 BENECIA AVE.
SUNNYVALE,  CA  94086
Applicant Contact DEEPAK GHANDI
Correspondent
ADVANCED CYTOMETRIX, INC.
995 BENECIA AVE.
SUNNYVALE,  CA  94086
Correspondent Contact DEEPAK GHANDI
Regulation Number878.4780
Classification Product Code
BTA  
Date Received09/14/1995
Decision Date 11/29/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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