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510(k) K923319

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

K923319 is an FDA 510(k) premarket notification submitted by Absentee Shawnee Bandage Group for the device "SHAWNEE PRODUCT KIT IV". The FDA issued a decision of Substantially Equivalent (kit, denovo) on June 17, 1993. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Absentee Shawnee Bandage Group has at least 2 other 510(k) clearances on record.

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)

Other clearances for product code KGX

  • K001240 — SERAGARD INJECTION PATCH (June 21, 2000)
  • K983368 — CARE BAND ANTIBACTERIAL BANDAGES (February 17, 1999)
  • K972914 — SYVEK PATCH (December 22, 1997)
  • K943314 — ADHESIVE BANDAGES WITH OTC DRUG (January 17, 1996)
  • K952606 — TARGETT PATCH (December 21, 1995)
  • 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)

FDA data resources