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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 K923319
Device Name SHAWNEE PRODUCT KIT IV
Applicant
Absentee Shawnee Bandage Group
1201 Holly Ln.
Tecumseh,  OK  74873
Applicant Contact EARL LITTLE
Correspondent
Absentee Shawnee Bandage Group
1201 Holly Ln.
Tecumseh,  OK  74873
Correspondent Contact EARL LITTLE
Regulation Number880.5240
Classification Product Code
KGX  
Date Received07/07/1992
Decision Date 06/17/1993
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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