Cleared Traditional

K915670 - MICROAIRE MODEL 2600 (FDA 510(k) Clearance)

K915670 · Microaire · General & Plastic Surgery device

Mar 1992

Decision

90d

Days

Class 1

Risk

K915670 is an FDA 510(k) clearance for the MICROAIRE MODEL 2600. This device is classified as a Applier, Staple, Surgical, (Class I - General Controls, product code GEF).

Submitted by Microaire (Valencia, US). The FDA issued a Cleared decision on March 18, 1992, 90 days after receiving the submission on December 19, 1991.

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

Submission Details

510(k) Number	K915670 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 19, 1991
Decision Date	March 18, 1992
Days to Decision	90 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement