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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Airbrush
510(k) Number K932997
Device Name MICROPREP CAVITY PREPERATION SYSTEM
Applicant
Sunrise Technologies, Inc.
47257 Fremont Blvd.
Fremont,  CA  94538
Applicant Contact CHARLES ROSE
Correspondent
Sunrise Technologies, Inc.
47257 Fremont Blvd.
Fremont,  CA  94538
Correspondent Contact CHARLES ROSE
Regulation Number872.6080
Classification Product Code
KOJ  
Date Received06/18/1993
Decision Date 04/25/1994
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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