Cleared Traditional

NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS

K130117 · Network Medical Products, Ltd. · Ophthalmic

Oct 2013

Decision

286d

Days

Class 2

Risk

About This 510(k) Submission

K130117 is an FDA 510(k) clearance for the NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS, a Sponge, Ophthalmic (Class II — Special Controls, product code HOZ), submitted by Network Medical Products, Ltd. (Ripon, GB). The FDA issued a Cleared decision on October 29, 2013, 286 days after receiving the submission on January 16, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4790.

Submission Details

510(k) Number	K130117 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 16, 2013
Decision Date	October 29, 2013
Days to Decision	286 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF