PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE


Device Classification Name

powered laser surgical instrument

510(k) Number K080731
Device Name PHARAON 980 ENDO/EXO, OSYFIBRE 600, CONTROL4+ HANDPIECE
Applicant
OSYRIS
121 rue chanzy, bp 90140
hellemmes , france, 

FR

f59260

Applicant Contact jaouad zemmouri
Correspondent
OSYRIS
121 rue chanzy, bp 90140
hellemmes , france, 

FR

f59260

Correspodent Contact jaouad zemmouri
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 03/14/2008
Decision Date 07/17/2008
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