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510(k) K961405

ALBA HEALTH PAS WRAP SYSTEM by Alba-Waldensian, Inc. — Product Code JOW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 26, 1996
Date Received
April 11, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sleeve, Limb, Compressible
Device Class
Class II
Regulation Number
870.5800
Review Panel
CV
Submission Type

Other clearances by Alba-Waldensian, Inc.

  • K020592 — ALBAHEALTH C.A.L.M. SLEEVE, MODEL 59001 (April 3, 2002)
  • 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)
  • K780547 — STERILE ORTHOPEDIC STOCKINETTE (April 10, 1978)
  • K771913 — HEEL/ELBOW PROTECTOR (November 15, 1977)

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