Home / 510(k) Clearances / K830246

510(k) K830246

CAST SHOE, CAST BOOT by Warm & Form, Orthopedic Materials — Product Code JQB

K830246 is an FDA 510(k) premarket notification submitted by Warm & Form, Orthopedic Materials for the device "CAST SHOE, CAST BOOT". The FDA issued a decision of Substantially Equivalent on February 18, 1983. The device falls under product code JQB (Kinetic Method, Gamma-Glutamyl Transpeptidase), a Class I device regulated under 21 CFR 862.1360. Warm & Form, Orthopedic Materials has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1983
Date Received
January 25, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kinetic Method, Gamma-Glutamyl Transpeptidase
Device Class
Class I
Regulation Number
862.1360
Review Panel
CH
Submission Type

Other clearances by Warm & Form, Orthopedic Materials

  • K830245 — HEAD HALTER (March 9, 1983)
  • K830244 — TRACTION ACCESSORIES (March 9, 1983)
  • K830243 — ABDUCTION PILLOW (March 8, 1983)
  • K823660 — UNIVERSAL BUCKS TRACTION (December 30, 1982)
  • K823664 — UNIVERSAL SLING, SLING & SWATHE (December 30, 1982)
  • K823661 — CLAVICLE SUPPORT (December 30, 1982)
  • K823663 — ABDOMINAL BINDER (December 30, 1982)
  • K823658 — DELUXE KNEE IMMOBILIZER(UNIVERSAL) (December 30, 1982)
  • K823665 — ROTATION BOOT (December 30, 1982)
  • K823667 — CERVICAL COLLAR (December 30, 1982)

Other clearances for product code JQB

  • K974000 — Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30 (November 4, 1997)
  • K973157 — LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET (October 10, 1997)
  • K971466 — SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT) (May 6, 1997)
  • K964457 — ROCHE COBAS IBTEGRA REAGENT CASSETTES (January 13, 1997)
  • K964916 — GAMMA-GLUTAMYL TRANSPEPTIDASE (January 10, 1997)
  • K955770 — GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM (September 9, 1996)
  • K945800 — Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05 (June 9, 1995)
  • K946192 — HICHEM Y-GT REAGENT KIT (May 2, 1995)
  • K942962 — GGT QVET (December 7, 1994)
  • K935984 — GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419 (July 20, 1994)

FDA data resources