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510(k) K770346

ORTHOPEDIC STOCKINETTE by Convertors — Product Code ILG

K770346 is an FDA 510(k) premarket notification submitted by Convertors for the device "ORTHOPEDIC STOCKINETTE". The FDA issued a decision of Substantially Equivalent on March 7, 1977. The device falls under product code ILG (Stocking, Elastic), a Class I device regulated under 21 CFR 890.3475. Convertors has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1977
Date Received
February 22, 1977
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 by Convertors

  • K780627 — SURG-O-PAK, GOWNS, SHEETS, AND TOWELS (July 11, 1979)
  • K790234 — DRAPE PACKS, SURGICAL GOWNS (February 22, 1979)
  • K781959 — SURGICAL GOWNS, SHEETS (January 10, 1979)
  • K781534 — SURG-O-PAK PREP PAD (October 24, 1978)
  • K781099 — SURGICAL GOWNS AND DRAPES (August 14, 1978)
  • K780169 — MASK, SURGICAL (February 13, 1978)
  • K771929 — PEDIATRICS GOWN (November 16, 1977)
  • K770933 — BIO-SHIELD CSR WRAP (September 2, 1977)
  • K761034 — SURGEX SURGICAL SPONGE (January 5, 1977)

Other clearances for product code ILG

  • K833437 — ORTHOPEDIC STOCKINETTE (November 3, 1983)
  • K831540 — COMPRESSOGRIP ELASTIC STUMP SHRINKER# (June 8, 1983)
  • K780612 — STOCKINETTE, STERILE (April 19, 1978)
  • K780547 — STERILE ORTHOPEDIC STOCKINETTE (April 10, 1978)
  • K770173 — STOCKINETTE (February 8, 1977)
  • K760817 — ORTHOPEDIC TUBULAR STOCKINETTE (October 20, 1976)
  • K760576 — TOURNIWRAP BANDAGE (October 5, 1976)

FDA data resources