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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 K970589
Device Name MICROETCHER AP
Applicant
Danville Engineering, Inc.
2021 Omega Dr.
San Ramon,  CA  94583
Applicant Contact CRAIG R BRUNS
Correspondent
Danville Engineering, Inc.
2021 Omega Dr.
San Ramon,  CA  94583
Correspondent Contact CRAIG R BRUNS
Regulation Number872.6080
Classification Product Code
KOJ  
Date Received02/18/1997
Decision Date 09/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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