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510(k) K923319

SHAWNEE PRODUCT KIT IV by Absentee Shawnee Bandage Group — Product Code KGX

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
June 17, 1993
Date Received
July 7, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tape And Bandage, Adhesive
Device Class
Class I
Regulation Number
880.5240
Review Panel
SU
Submission Type

Other clearances by Absentee Shawnee Bandage Group

  • K921761 — SHAWNEE PRODUCTS KIT II (March 18, 1993)
  • K921762 — SHAWNEE PRODUCTS KIT I (January 6, 1993)

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  • K943314 — ADHESIVE BANDAGES WITH OTC DRUG (January 17, 1996)
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  • K954007 — PARALLEL (November 22, 1995)
  • K944587 — DERMIVIEW HYPOALLERGENIC CLEAR TAPE (October 30, 1995)
  • K944588 — STERILE PLASTIC DRESSING (November 7, 1994)
  • K941788 — BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (October 3, 1994)
  • K940536 — BAND-AID(TM) BRAND ADHESIVE BANDAGE (October 3, 1994)