PHACOGARD


Device Classification Name

unit, phacofragmentation

510(k) Number K002932
Device Name PHACOGARD
Original Applicant
SYNTEC, INC.
733 mansion rd.
winfield, 
MO 
63389

Original Contact jim easley
Regulation Number 886.4670
Classification Product Code
HQC  
Date Received 09/20/2000
Decision Date 01/04/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

Type Traditional
Reviewed by Third Party No

Combination Product

No