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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape And Bandage, Adhesive
510(k) Number K821490
Device Name SILKAFIX ADHESIVE PLASTER
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 Number880.5240
Classification Product Code
KGX  
Date Received05/18/1982
Decision Date 06/02/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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