Cleared Traditional

K780489 - SPINE BOARD (FDA 510(k) Clearance)

K780489 · Marullo, Baldwin, Frieden, Gatewood, · Physical Medicine device

Apr 1978

Decision

16d

Days

Class 1

Risk

K780489 is an FDA 510(k) clearance for the SPINE BOARD. This device is classified as a Orthosis, Cervical-thoracic, Rigid (Class I - General Controls, product code IQF).

Submitted by Marullo, Baldwin, Frieden, Gatewood, (Mchenry, US). The FDA issued a Cleared decision on April 12, 1978, 16 days after receiving the submission on March 27, 1978.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3490.

Submission Details

510(k) Number	K780489 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 27, 1978
Decision Date	April 12, 1978
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—