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510(k) K833437

ORTHOPEDIC STOCKINETTE by Northern Medical Surgical, Inc. — Product Code ILG

K833437 is an FDA 510(k) premarket notification submitted by Northern Medical Surgical, Inc. for the device "ORTHOPEDIC STOCKINETTE". The FDA issued a decision of Substantially Equivalent on November 3, 1983. The device falls under product code ILG (Stocking, Elastic), a Class I device regulated under 21 CFR 890.3475.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1983
Date Received
October 5, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stocking, Elastic
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type

Other clearances for product code ILG

  • K831540 — COMPRESSOGRIP ELASTIC STUMP SHRINKER# (June 8, 1983)
  • K780612 — STOCKINETTE, STERILE (April 19, 1978)
  • K780547 — STERILE ORTHOPEDIC STOCKINETTE (April 10, 1978)
  • K770346 — ORTHOPEDIC STOCKINETTE (March 7, 1977)
  • K770173 — STOCKINETTE (February 8, 1977)
  • K760817 — ORTHOPEDIC TUBULAR STOCKINETTE (October 20, 1976)
  • K760576 — TOURNIWRAP BANDAGE (October 5, 1976)

FDA data resources