MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES


Device Classification Name

sponge, ophthalmic

510(k) Number K011191
Device Name MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGES
Original Applicant
MEDTRONIC XOMED, INC.
6743 southpoint dr. north
jacksonville, 
FL 
32216

Original Contact diana taylor
Regulation Number 886.4790
Classification Product Code
HOZ  
Date Received 04/19/2001
Decision Date 06/26/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

Type Traditional
Reviewed by Third Party No

Combination Product

No