BENJAMIN ENVOY PHACO HANDPIECE


Device Classification Name

unit, phacofragmentation

510(k) Number K022833
Device Name BENJAMIN ENVOY PHACO HANDPIECE
Original Applicant
BENJAMIN BIOMEDICAL, INC.
962 allegro ln.
apollo beach, 
FL 
33572

Original Contact arthur ward
Regulation Number 886.4670
Classification Product Code
HQC  
Date Received 08/26/2002
Decision Date 09/09/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No