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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
Applicant Contact CRAIG HARSHMAN
Correspondent
I.C Medical, Inc.
2002 W. Quail Ave.
Phoenix,  AZ  85027
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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