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510(k) K812401

CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O by Surgical Appliance Industries, Inc. — Product Code IPT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1981
Date Received
August 20, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Surgical Appliance Industries, Inc.

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  • K813416 — EXTERNAL BREAST PROSTHESIS (January 18, 1982)
  • K812423 — NEOPRENE KNEE SUPPORT (September 14, 1981)
  • K812422 — CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS (September 14, 1981)
  • K811689 — CYLINDER KNEE CAST/SPLINT (June 25, 1981)
  • K811690 — ANKLE-FOOT CAST/SPLINT (June 25, 1981)
  • K811494 — LUMBO-SACRAL FLEXION ORTHOSIS (June 16, 1981)

Other clearances for product code IPT

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  • K821645 — BACK SKPPORTS (June 11, 1982)
  • K811750 — MULTITUBULAR THORACIC AIR SPLINTS (July 20, 1981)
  • K761128 — LATERAL TRUNK SUPPORTS (December 2, 1976)