Cleared Traditional

K973420 - CLINITEX CAST PADDING
(FDA 510(k) Clearance)

K973420 · Clinitex Medical Corp. · Orthopedic device

Dec 1997

Decision

90d

Days

Class 1

Risk

K973420 is an FDA 510(k) clearance for the CLINITEX CAST PADDING. This device is classified as a Component, Cast (Class I - General Controls, product code LGF).

Submitted by Clinitex Medical Corp. (Huntersville, US). The FDA issued a Cleared decision on December 9, 1997, 90 days after receiving the submission on September 10, 1997.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.5940.

Submission Details

510(k) Number	K973420 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 10, 1997
Decision Date	December 09, 1997
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement