TANDA MAX


Device Classification Name

powered light based non-laser surgical instrument

510(k) Number K103415
Device Name TANDA MAX
Applicant
PHAROS LIFE CORPORATION
11-380 jamieson pkwy
cambridge, ontario, 

CA

n3c 4n4

Applicant Contact gordon wehner
Regulation Number 878.4810
Classification Product Code
ONE  
Date Received 11/22/2010
Decision Date 01/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No