APL MEDICAL SYSTEM


Device Classification Name

powered laser surgical instrument

510(k) Number K072344
Device Name APL MEDICAL SYSTEM
Applicant
BIOS S.R.L.
via guido rossa, 10/12
vimodrone (milan), 

IT

i-20090

Applicant Contact aldo casalino
Correspondent
BIOS S.R.L.
via guido rossa, 10/12
vimodrone (milan), 

IT

i-20090

Correspodent Contact aldo casalino
Regulation Number 878.4810
Classification Product Code
GEX  
Subsequent Product Code
FTC  
Date Received 08/21/2007
Decision Date 12/03/2007
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