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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 K852521
Device Name SATLEC PROPHY UNIT PU 3055
Applicant
Spelna, Inc.
P.O. Box 3395
Fredericksburg,  VA  22402
Applicant Contact ROBERT E MCDONNELL
Correspondent
Spelna, Inc.
P.O. Box 3395
Fredericksburg,  VA  22402
Correspondent Contact ROBERT E MCDONNELL
Regulation Number872.6080
Classification Product Code
KOJ  
Date Received06/14/1985
Decision Date 07/31/1985
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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