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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Cast
510(k) Number K810111
Device Name CELLONA PLASTER VARNISH
Applicant
Secol Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Secol Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.3025
Classification Product Code
ITG  
Date Received01/16/1981
Decision Date 02/04/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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