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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 K002753
Device Name SPARTAN A-10
Applicant
Spartan Ultrasonics, Inc.
1663 Fenton Business Park Ct.
Fenton,  MO  63026
Applicant Contact ALDO E EAGLE
Correspondent
Spartan Ultrasonics, Inc.
1663 Fenton Business Park Ct.
Fenton,  MO  63026
Correspondent Contact ALDO E EAGLE
Regulation Number872.4850
Classification Product Code
ELC  
Date Received09/05/2000
Decision Date 12/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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