Home / 510(k) Clearances / K780489

510(k) K780489

SPINE BOARD by Marullo, Baldwin, Frieden, Gatewood, — Product Code IQF

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 12, 1978
Date Received: March 27, 1978
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Orthosis, Cervical-Thoracic, Rigid
Device Class: Class I
Regulation Number: 890.3490
Review Panel: PM
Submission Type