FLEXLITE CAMERA


Device Classification Name

arthroscope

510(k) Number K122134
Device Name FLEXLITE CAMERA
Applicant
SPINE VIEW, INC.
48810 kato rd. suite 100e
fremont, 
CA 
94538

Applicant Contact mbithi muthini
Correspondent
SPINE VIEW, INC.
48810 kato rd. suite 100e
fremont, 
CA 
94538

Correspodent Contact mbithi muthini
Regulation Number 888.1100
Classification Product Code
HRX  
Date Received 07/18/2012
Decision Date 12/27/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No