Cleared Traditional

K970722 - EYE TRAY
(FDA 510(k) Clearance)

K970722 · Trinity Laboratories, Inc. · General Hospital

Mar 1997

Decision

32d

Days

Class 2

Risk

K970722 is an FDA 510(k) clearance for the EYE TRAY. This device is classified as a Drape, Surgical (Class II — Special Controls, product code KKX).

Submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on March 31, 1997, 32 days after receiving the submission on February 27, 1997.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number	K970722 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 27, 1997
Decision Date	March 31, 1997
Days to Decision	32 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement