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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 K003840
Device Name CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES
Applicant
I.C. MEDICAL, INC.
2002 W. QUAIL AVE.
PHOENIX,  AZ  85027 -2610
Applicant Contact CRAIG HARSHMAN
Correspondent
I.C. MEDICAL, INC.
2002 W. QUAIL AVE.
PHOENIX,  AZ  85027 -2610
Correspondent Contact CRAIG HARSHMAN
Regulation Number878.5070
Classification Product Code
FYD  
Date Received12/12/2000
Decision Date 02/01/2001
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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