Cleared Traditional

K972810 - OPT80 THE TRANSPORTABLE (OPT80)
(FDA 510(k) Clearance)

K972810 · O.P.T. USA, Inc. · General & Plastic Surgery device

Aug 1997

Decision

29d

Days

Class 1

Risk

K972810 is an FDA 510(k) clearance for the OPT80 THE TRANSPORTABLE (OPT80). This device is classified as a Table, Operating-room, Ac-powered (Class I - General Controls, product code FQO).

Submitted by O.P.T. USA, Inc. (Brooklyn, US). The FDA issued a Cleared decision on August 26, 1997, 29 days after receiving the submission on July 28, 1997.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4960.

Submission Details

510(k) Number	K972810 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 28, 1997
Decision Date	August 26, 1997
Days to Decision	29 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF