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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Ultrasonic
510(k) Number K990546
Device Name DELSONIC 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 Number872.4850
Classification Product Code
ELC  
Date Received02/22/1999
Decision Date 11/05/1999
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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