Home / 510(k) Clearances / K810110

510(k) K810110

COBBLER'S CHIP SPLINTS by Secol Co. — Product Code LGF

K810110 is an FDA 510(k) premarket notification submitted by Secol Co. for the device "COBBLER'S CHIP SPLINTS". The FDA issued a decision of Substantially Equivalent on January 26, 1981. The device falls under product code LGF (Component, Cast), a Class I device regulated under 21 CFR 888.5940. Secol Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1981
Date Received
January 16, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Component, Cast
Device Class
Class I
Regulation Number
888.5940
Review Panel
OR
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)
  • K802794 — PRO-OPHTA STICKS (December 22, 1980)
  • K802793 — LOMATUELL OINTMENT DRESSING (December 18, 1980)
  • K802791 — ZINC PASTE BANDAGE (December 17, 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 LGF

  • K043526 — SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC (March 10, 2005)
  • K973417 — CLINITEX STOCKINETTE (December 9, 1997)
  • K973420 — CLINITEX CAST PADDING (December 9, 1997)
  • K955320 — PROTEC COTTON PADDING BANDAGE (January 26, 1996)
  • K932507 — QUICK-CAST IMMOBILIZER (February 23, 1994)
  • K931672 — CARAPACE STERILE CAST PADDING (December 15, 1993)
  • K910274 — ARTIFLEX(TM) (March 5, 1991)
  • K903946 — COOL CAST(R) (December 31, 1990)
  • K896634 — CARAGLAS XTRA SYNTHETIC CASTING TAPE (June 14, 1990)
  • K883294 — SYNTHETIC CAST TAPE (August 30, 1988)

FDA data resources