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510(k) K811704

MULTITUBULAR AIR SPLINT KIT by Roger Cestac & Assoc. — Product Code IQI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1981
Date Received
June 16, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Limb Brace
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type

Other clearances by Roger Cestac & Assoc.

  • K811750 — MULTITUBULAR THORACIC AIR SPLINTS (July 20, 1981)

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