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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 K990545
Device Name JETSONIC 2000
Applicant
Sds Dental, Inc.
5101 NW 21st Ave. NW
Suite 141
Fort Lauderdale,  FL  33309
Applicant Contact CESAR CORAL
Correspondent
Sds Dental, Inc.
5101 NW 21st Ave. NW
Suite 141
Fort Lauderdale,  FL  33309
Correspondent Contact CESAR CORAL
Regulation Number872.6080
Classification Product Code
KOJ  
Date Received02/22/1999
Decision Date 08/11/1999
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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