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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 K022583
Device Name FLASH 1
Applicant
Emed, Inc.
191 W. Wilbur Rd.
Suite 103
Thousand Oaks,  CA  91360
Applicant Contact KENNETH KARASIUK
Correspondent
Emed, Inc.
191 W. Wilbur Rd.
Suite 103
Thousand Oaks,  CA  91360
Correspondent Contact KENNETH KARASIUK
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/05/2002
Decision Date 10/31/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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