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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 K983463
Device Name SURECAUT DIAMOND LASER KNIFE
Applicant
Clinicon Corp.
2752 Loker Ave. W.
Carlsbad,  CA  92008
Applicant Contact GERALD S PALECKI
Correspondent
Clinicon Corp.
2752 Loker Ave. W.
Carlsbad,  CA  92008
Correspondent Contact GERALD S PALECKI
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/01/1998
Decision Date 12/11/1998
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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