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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 K970143
Device Name C4
Applicant
Clinicon Corp.
2260 Rutherford Rd., #101
Carlsbad,  CA  92008
Applicant Contact ALAN BUNTING
Correspondent
Clinicon Corp.
2260 Rutherford Rd., #101
Carlsbad,  CA  92008
Correspondent Contact ALAN BUNTING
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/15/1997
Decision Date 10/29/1997
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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