STARLIGHT, MODEL PD9012


Device Classification Name

powered laser surgical instrument

510(k) Number K073317
Device Name STARLIGHT, MODEL PD9012
Applicant
F.P. RUBINSTEIN Y CIA S.R.L.
david luque 519
cordoba, cba, 

AR

x5004akm

Applicant Contact haydee n demarco
Correspondent
F.P. RUBINSTEIN Y CIA S.R.L.
david luque 519
cordoba, cba, 

AR

x5004akm

Correspodent Contact haydee n demarco
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 11/26/2007
Decision Date 09/03/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No