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510(k) K780547

STERILE ORTHOPEDIC STOCKINETTE by Alba-Waldensian, Inc. — Product Code ILG

K780547 is an FDA 510(k) premarket notification submitted by Alba-Waldensian, Inc. for the device "STERILE ORTHOPEDIC STOCKINETTE". The FDA issued a decision of Substantially Equivalent on April 10, 1978. The device falls under product code ILG (Stocking, Elastic), a Class I device regulated under 21 CFR 890.3475. Alba-Waldensian, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1978
Date Received
April 5, 1978
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 Alba-Waldensian, Inc.

  • K020592 — ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001 (April 3, 2002)
  • K961405 — ALBA HEALTH PAS WRAP SYSTEM (December 26, 1996)
  • K852091 — ALBA DRY BURN PAD (June 13, 1985)
  • K792357 — STERILE IMPERVIOUS ORTHOPEDIC STOCKIN (December 18, 1979)
  • K781964 — COMPRESSION DEVICES, LIMB (December 12, 1978)
  • K780570 — TUBULAR DRESSING RETAINER (April 19, 1978)
  • K771913 — HEEL/ELBOW PROTECTOR (November 15, 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)
  • 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