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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 K911068
Device Name 29540 DYNASURG ELECTRIC HANDPIECE AND IRR. SYSTEM
Applicant
Micro Motors, Inc.
151 E. Columbine Ave.
Santa Ana,  CA  92707
Applicant Contact RUSS REINSCH
Correspondent
Micro Motors, Inc.
151 E. Columbine Ave.
Santa Ana,  CA  92707
Correspondent Contact RUSS REINSCH
Regulation Number872.4200
Classification Product Code
EFB  
Date Received03/11/1991
Decision Date 05/15/1991
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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