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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Stocking, Medical Support (For General Medical Purposes)
510(k) Number K821259
Device Name VITASAN
Applicant
SELOMAS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SELOMAS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number880.5780
Classification Product Code
FQL  
Date Received04/30/1982
Decision Date 06/23/1982
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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