Cleared Traditional

MICROTEK'S SURGICAL LAMP HANDLE & COVER

K901154 · Microbio-Medics, Inc. · General & Plastic Surgery
Mar 1990
Decision
7d
Days
Class 2
Risk

About This 510(k) Submission

K901154 is an FDA 510(k) clearance for the MICROTEK'S SURGICAL LAMP HANDLE & COVER, a Light, Surgical, Accessories (Class II — Special Controls, product code FTA), submitted by Microbio-Medics, Inc. (Tucker, US). The FDA issued a Cleared decision on March 20, 1990, 7 days after receiving the submission on March 13, 1990. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number K901154 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 1990
Decision Date March 20, 1990
Days to Decision 7 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code FTA — Light, Surgical, Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4580

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