Cleared Traditional

MODIFICATION OF ANTERIOR SEGMENT ELECTRODES

K933527 · Mira, Inc. · Orthopedic

Jan 1994

Decision

189d

Days

Class 1

Risk

About This 510(k) Submission

K933527 is an FDA 510(k) clearance for the MODIFICATION OF ANTERIOR SEGMENT ELECTRODES, a Impactor (Class I — General Controls, product code HWA), submitted by Mira, Inc. (Waltham, US). The FDA issued a Cleared decision on January 25, 1994, 189 days after receiving the submission on July 20, 1993. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number	K933527 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 20, 1993
Decision Date	January 25, 1994
Days to Decision	189 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement