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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleaner, Ultrasonic, Medical Instrument
510(k) Number K852527
Device Name SATALEC SEPTOSONIC SC 80/SC 120
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 Number880.6150
Classification Product Code
FLG  
Date Received06/14/1985
Decision Date 01/03/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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