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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 K974057
Device Name DENTEK LD 15 LASERSYSTEM
Applicant
Dentek Lasersystems Produktions Ges.M.B.H.
1819 S. May St., 2f
Chicago,  IL  60608
Applicant Contact ROBERT W BAUER
Correspondent
Dentek Lasersystems Produktions Ges.M.B.H.
1819 S. May St., 2f
Chicago,  IL  60608
Correspondent Contact ROBERT W BAUER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/27/1997
Decision Date 04/21/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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