Cleared Traditional

K010559 - SAUFLON MULTI LENS CARE SYSTEM
(FDA 510(k) Clearance)

K010559 · Sauflon Pharmaceuticals, Ltd. · Ophthalmic

Dec 2001

Decision

297d

Days

Class 2

Risk

K010559 is an FDA 510(k) clearance for the SAUFLON MULTI LENS CARE SYSTEM, a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN), submitted by Sauflon Pharmaceuticals, Ltd. (Twickenham, Middlesex, GB). The FDA issued a Cleared decision on December 20, 2001, 297 days after receiving the submission on February 26, 2001. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number	K010559 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 26, 2001
Decision Date	December 20, 2001
Days to Decision	297 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF