IPULSE, MODEL I400


Device Classification Name

powered laser surgical instrument

510(k) Number K080406
Device Name IPULSE, MODEL I400
Applicant
CYDEN LIMITED
technium, kings road
the docks
swansea, wales, 

GB

sa1 8ph

Applicant Contact micheal kiernan
Correspondent
CYDEN LIMITED
technium, kings road
the docks
swansea, wales, 

GB

sa1 8ph

Correspodent Contact micheal kiernan
Regulation Number 878.4810
Classification Product Code
GEX  
Date Received 02/14/2008
Decision Date 03/10/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No