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510(k) K811750

MULTITUBULAR THORACIC AIR SPLINTS by Roger Cestac & Assoc. — Product Code IPT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1981
Date Received
June 22, 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 Roger Cestac & Assoc.

  • K811704 — MULTITUBULAR AIR SPLINT KIT (July 1, 1981)

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  • K821645 — BACK SKPPORTS (June 11, 1982)
  • K812401 — CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O (September 14, 1981)
  • K761128 — LATERAL TRUNK SUPPORTS (December 2, 1976)