Cleared Traditional

SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES

K903303 · Spembly Medical , Ltd. · Ophthalmic
Oct 1990
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K903303 is an FDA 510(k) clearance for the SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES, a Unit, Cryophthalmic (Class II — Special Controls, product code HPS), submitted by Spembly Medical , Ltd. (England, GB). The FDA issued a Cleared decision on October 11, 1990, 79 days after receiving the submission on July 24, 1990. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4170.

Submission Details

510(k) Number K903303 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 1990
Decision Date October 11, 1990
Days to Decision 79 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HPS — Unit, Cryophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4170