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510(k) K821682

TRUNCAL ORTHOSIS by Surgical Appliance Industries, Inc. — Product Code IQE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1982
Date Received
June 8, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Lumbar
Device Class
Class I
Regulation Number
890.3490
Review Panel
PM
Submission Type

Other clearances by Surgical Appliance Industries, Inc.

  • K121106 — TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION G (April 27, 2012)
  • K813416 — EXTERNAL BREAST PROSTHESIS (January 18, 1982)
  • K812423 — NEOPRENE KNEE SUPPORT (September 14, 1981)
  • K812401 — CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O (September 14, 1981)
  • K812422 — CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS (September 14, 1981)
  • K811690 — ANKLE-FOOT CAST/SPLINT (June 25, 1981)
  • K811689 — CYLINDER KNEE CAST/SPLINT (June 25, 1981)
  • K811494 — LUMBO-SACRAL FLEXION ORTHOSIS (June 16, 1981)

Other clearances for product code IQE

  • K820051 — OBUS FORME ORTHOPEDIC BRACE, UPRIGHT (January 29, 1982)
  • K812719 — PROSANA BELT (October 6, 1981)
  • K810450 — TRUNCAL ORTHOSIS (March 4, 1981)