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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K900511
Device Name I.C. MEDICAL ADJUSTABLE DIRECT COUPLER
Applicant
I.C Medical, Inc.
14449 N. 22nd St.
Phoenix,  AZ  85022
Applicant Contact IOAN COSMESCU
Correspondent
I.C Medical, Inc.
14449 N. 22nd St.
Phoenix,  AZ  85022
Correspondent Contact IOAN COSMESCU
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/02/1990
Decision Date 05/01/1990
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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