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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 K922228
Device Name 2ND SKIN STERILE ADHESIVE STRIP
Applicant
Spenco Medical Corp.
P.O. Box 2501
Waco,  TX  76702
Applicant Contact STAN A CHAMBERS
Correspondent
Spenco Medical Corp.
P.O. Box 2501
Waco,  TX  76702
Correspondent Contact STAN A CHAMBERS
Regulation Number880.5240
Classification Product Code
KGX  
Date Received05/12/1992
Decision Date 12/11/1992
Decision Substantially Equivalent - Kit (SESK)
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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