OCUSYSTEM ART ADVANTAGE, MODEL 995


Device Classification Name

unit, phacofragmentation

510(k) Number K991852
Device Name OCUSYSTEM ART ADVANTAGE, MODEL 995
Applicant
SURGICAL DESIGN CORP.
1050 connecticut avenue, nw
washington, 
DC 
20036 -5339

Applicant Contact wayne h matelski
Correspondent
SURGICAL DESIGN CORP.
1050 connecticut avenue, nw
washington, 
DC 
20036 -5339

Correspodent Contact wayne h matelski
Regulation Number 886.4670
Classification Product Code
HQC  
Date Received 06/01/1999
Decision Date 07/07/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No