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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 K000805
Device Name KAVO K.E.Y. LASER 1242
Applicant
KAVO AMERICA
340 EAST MAIN ST.
LAKE ZURICH,  IL  60047
Applicant Contact JOHN FRANZ
Correspondent
KAVO AMERICA
340 EAST MAIN ST.
LAKE ZURICH,  IL  60047
Correspondent Contact JOHN FRANZ
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/13/2000
Decision Date 05/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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