Cleared Special

MODIFICATION TO: OCU-FILM TIP COVER

K070534 · Reichert, Inc. · Ophthalmic
Mar 2007
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K070534 is an FDA 510(k) clearance for the MODIFICATION TO: OCU-FILM TIP COVER, a Tonometer, Manual (Class II — Special Controls, product code HKY), submitted by Reichert, Inc. (Depew, US). The FDA issued a Cleared decision on March 27, 2007, 29 days after receiving the submission on February 26, 2007. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1930.

Submission Details

510(k) Number K070534 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 2007
Decision Date March 27, 2007
Days to Decision 29 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HKY — Tonometer, Manual
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1930