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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K042710
Device Name SURGITRON RADIOLASE II
Applicant
Ellman Int'L, Inc.
3333 Royal Ave.
Oceanside,  NY  11572
Applicant Contact FRANK LIN
Correspondent
Ellman Int'L, Inc.
3333 Royal Ave.
Oceanside,  NY  11572
Correspondent Contact FRANK LIN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/30/2004
Decision Date 04/07/2005
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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