SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE


Device Classification Name

arthroscope

510(k) Number K081051
Device Name SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE
Applicant
SPINE VIEW, INC.
48541 warm springs blvd.
suite 507
fremont, 
CA 
94539

Applicant Contact roy chin
Correspondent
SPINE VIEW, INC.
48541 warm springs blvd.
suite 507
fremont, 
CA 
94539

Correspodent Contact roy chin
Regulation Number 888.1100
Classification Product Code
HRX  
Subsequent Product Code
GEI  
Date Received 04/14/2008
Decision Date 08/07/2008
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