IRIS RETRACTING PHACOEMULSIFICATION SLEEVE


Device Classification Name

unit, phacofragmentation

510(k) Number K002812
Device Name IRIS RETRACTING PHACOEMULSIFICATION SLEEVE
Original Applicant
MICHAEL REYNARD, M.D.
1301-20th st., #260
santa monica, 
CA 
90404

Original Contact michael reynard
Regulation Number 886.4670
Classification Product Code
HQC  
Date Received 09/08/2000
Decision Date 11/08/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

Type Traditional
Reviewed by Third Party No

Combination Product

No