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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 K843915
Device Name MINI-HALO CO2 LASER SYSTEM
Applicant
CooperVision, Inc.
P.O. Box 19587
Irvine,  CA  92713
Applicant Contact DOUGLAS G ALLEN
Correspondent
CooperVision, Inc.
P.O. Box 19587
Irvine,  CA  92713
Correspondent Contact DOUGLAS G ALLEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/04/1984
Decision Date 05/10/1985
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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