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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K970002
Device Name STERILE WATER PUMP
Applicant
Micro Motors, Inc.
151 E. Columbine Ave.
Santa Ana,  CA  92707
Applicant Contact CHARLES E STRAIT
Correspondent
Micro Motors, Inc.
151 E. Columbine Ave.
Santa Ana,  CA  92707
Correspondent Contact CHARLES E STRAIT
Regulation Number872.6640
Classification Product Code
EIA  
Date Received01/02/1997
Decision Date 03/05/1997
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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