Cleared Traditional

KEELER CRYO MASTER & PROBES

K992954 · Keeler Instruments, Inc. · Ophthalmic
Dec 1999
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K992954 is an FDA 510(k) clearance for the KEELER CRYO MASTER & PROBES, a Unit, Cryophthalmic, Ac-powered (Class II — Special Controls, product code HRN), submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on December 21, 1999, 111 days after receiving the submission on September 1, 1999. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4170.

Submission Details

510(k) Number K992954 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 1999
Decision Date December 21, 1999
Days to Decision 111 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HRN — Unit, Cryophthalmic, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4170

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