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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K900798
Device Name LYNX LOW-SPEED HANDPIECE
Applicant
Air Motors Technologies
Shelomi Industrial Zone, P.O.
Box 1120
Shelomi,  IL 22832
Applicant Contact MOSHE MELLER
Correspondent
Air Motors Technologies
Shelomi Industrial Zone, P.O.
Box 1120
Shelomi,  IL 22832
Correspondent Contact MOSHE MELLER
Regulation Number872.4200
Classification Product Code
EFB  
Date Received02/20/1990
Decision Date 06/27/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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