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510(k) K792357

STERILE IMPERVIOUS ORTHOPEDIC STOCKIN by Alba-Waldensian, Inc. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1979
Date Received
November 21, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Surgical
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
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)
  • K781964 — COMPRESSION DEVICES, LIMB (December 12, 1978)
  • K780570 — TUBULAR DRESSING RETAINER (April 19, 1978)
  • K780547 — STERILE ORTHOPEDIC STOCKINETTE (April 10, 1978)
  • K771913 — HEEL/ELBOW PROTECTOR (November 15, 1977)

Other clearances for product code KKX

  • K230645 — BeneHold™ Surgical Incise Drape with CHG antimicrobial II (October 25, 2023)
  • K222578 — 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) (May 18, 2023)
  • K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial (July 30, 2021)
  • K200238 — ControlRad Sterile Cover (April 26, 2020)
  • K163556 — MediClear PreOp (September 14, 2017)
  • K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX (June 24, 2015)
  • K141324 — HONGYU DISPOSABLE SURGICAL DRAPES (April 14, 2015)
  • K140195 — SURGICAL DRAPE (September 10, 2014)
  • K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES (August 18, 2014)
  • K141438 — WHITNEY MEDICAL SOLUTIONS ESHIELD (August 14, 2014)