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510(k) K802795

ORTHOPEDIC PADDING by Secol Co. — Product Code KGX

K802795 is an FDA 510(k) premarket notification submitted by Secol Co. for the device "ORTHOPEDIC PADDING". The FDA issued a decision of Substantially Equivalent on December 10, 1980. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Secol Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1980
Date Received
November 4, 1980
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 Secol Co.

  • K802790 — SOLVALINE (February 13, 1981)
  • K810111 — CELLONA PLASTER VARNISH (February 4, 1981)
  • K810109 — METAL SPLINTS (January 26, 1981)
  • K810110 — COBBLER'S CHIP SPLINTS (January 26, 1981)
  • K802794 — PRO-OPHTA STICKS (December 22, 1980)
  • K802793 — LOMATUELL OINTMENT DRESSING (December 18, 1980)
  • K802797 — O.R. DRAPES (December 17, 1980)
  • K802799 — EYE PADS (December 17, 1980)
  • K802786 — POROPLAST-EYE DRESSING (December 17, 1980)
  • K802787 — METALLINE DRESSINGS (December 17, 1980)

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)
  • K940536 — BAND-AID(TM) BRAND ADHESIVE BANDAGE (October 3, 1994)
  • K941788 — BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (October 3, 1994)

FDA data resources