Cleared Traditional

K874504 - MICRO-AIRE PULSE LAVAGE
(FDA 510(k) Clearance)

K874504 · Micro-Aire Surgical Instruments, Inc. · General Hospital

Dec 1987

Decision

57d

Days

Class 2

Risk

K874504 is an FDA 510(k) clearance for the MICRO-AIRE PULSE LAVAGE, a Lavage, Jet (Class II — Special Controls, product code FQH), submitted by Micro-Aire Surgical Instruments, Inc. (San Fernando, US). The FDA issued a Cleared decision on December 29, 1987, 57 days after receiving the submission on November 2, 1987. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5475.

Submission Details

510(k) Number	K874504 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 02, 1987
Decision Date	December 29, 1987
Days to Decision	57 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—