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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Direct Drive, Ac-Powered
510(k) Number K993188
Device Name ENDOSTEPPER 1
Applicant
Phytron- Elektronik GmbH
Industriestrasse 12
D-82194
Grobenzell,  DE
Applicant Contact CORNELIUS RIESS
Correspondent
Tuv Product Service, Inc.
1775 Old Highway 8
New Brighton,  MN  55112 -1891
Correspondent Contact CAROLE STAMP
Regulation Number872.4200
Classification Product Code
EKX  
Date Received09/23/1999
Decision Date 09/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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