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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 K921761
Device Name SHAWNEE PRODUCTS KIT II
Applicant
ABSENTEE SHAWNEE BANDAGE GROUP
P.O. BOX 369
1201 HOLLY LANE
TECUMSEH,  OH  74873
Applicant Contact EARL LITTLE
Correspondent
ABSENTEE SHAWNEE BANDAGE GROUP
P.O. BOX 369
1201 HOLLY LANE
TECUMSEH,  OH  74873
Correspondent Contact EARL LITTLE
Regulation Number880.5240
Classification Product Code
KGX  
Date Received04/14/1992
Decision Date 03/18/1993
Decision Substantially Equivalent - With Drug (SESD)
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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