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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 K983100
Device Name KAVO KEY LASER 1242
Applicant
Kavo America
340 E. Main St.
Lake Zurich,  IL  60047
Applicant Contact DOUGLAS COCHRANE
Correspondent
Kavo America
340 E. Main St.
Lake Zurich,  IL  60047
Correspondent Contact DOUGLAS COCHRANE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/03/1998
Decision Date 01/27/1999
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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