Cleared Traditional

K882793 - PMT FUKUSHIMA MICROSURGICAL INSTRUMENT LINE
(FDA 510(k) Clearance)

K882793 · Pmt Corp. · General & Plastic Surgery device

Jul 1988

Decision

12d

Days

Class 1

Risk

K882793 is an FDA 510(k) clearance for the PMT FUKUSHIMA MICROSURGICAL INSTRUMENT LINE. This device is classified as a Spatula, Surgical, General & Plastic Surgery (Class I - General Controls, product code GAF).

Submitted by Pmt Corp. (Chanhassen, US). The FDA issued a Cleared decision on July 18, 1988, 12 days after receiving the submission on July 6, 1988.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K882793 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 06, 1988
Decision Date	July 18, 1988
Days to Decision	12 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—