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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K910927
Device Name SPENCIO SKIN GUARD KIT
Applicant
Spenco Medical Corp.
P.O. Box 2501
Waco,  TX  76702
Applicant Contact JAMES E MCGOWAN
Correspondent
Spenco Medical Corp.
P.O. Box 2501
Waco,  TX  76702
Correspondent Contact JAMES E MCGOWAN
Regulation Number880.5090
Classification Product Code
KMF  
Date Received03/05/1991
Decision Date 06/03/1991
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
Predetermined Change
Control Plan Authorized		 No
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