DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES


Device Classification Name

lens, contact, polymethylmethacrylate, diagnostic

510(k) Number K030054
Device Name DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES
Original Applicant
FCI OPHTHALMICS, INC.
344 annabelle point rd.
centerville, 
MA 
02632 -2402

Original Contact hillard welch
Regulation Number 886.1385
Classification Product Code
HJK  
Subsequent Product Codes
HMX   HNN  
Date Received 01/06/2003
Decision Date 02/26/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No