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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Unit, Oral Irrigation
510(k) Number K904850
Device Name DUAL AND SINGLE IRR. SYSTEMS MODELS 29550 & 29555
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 Number872.6510
Classification Product Code
EFS  
Date Received10/29/1990
Decision Date 01/25/1991
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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