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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 K990060
Device Name MACH 7
Applicant
Kreativ, Inc.
9025 Balboa Ave.
San Diego,  CA  92123
Applicant Contact JOSEPH FOREHAND
Correspondent
Kreativ, Inc.
9025 Balboa Ave.
San Diego,  CA  92123
Correspondent Contact JOSEPH FOREHAND
Regulation Number872.6080
Classification Product Code
KOJ  
Date Received01/08/1999
Decision Date 06/15/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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