VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES


the company

Device Classification Name

cannula, ophthalmic

510(k) Number K000457
Device Name VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES
Original Applicant
RETINALABS.COM
1776 peachtree st.
200 north
atlanta, 
GA 
30309

Original Contact frank tighe
Regulation Number 886.4350
Classification Product Code
HMX  
Date Received 02/11/2000
Decision Date 05/09/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

Type Traditional
Reviewed by Third Party No

Combination Product

No