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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 K980216
Device Name KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6
Applicant
KREATIV, INC.
1517 INDUSTRIAL WAY, S.W.
ALBANY,  OR  97321
Applicant Contact JOE FOREHAND
Correspondent
KREATIV, INC.
1517 INDUSTRIAL WAY, S.W.
ALBANY,  OR  97321
Correspondent Contact JOE FOREHAND
Regulation Number872.6080
Classification Product Code
KOJ  
Date Received01/21/1998
Decision Date 06/16/1998
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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