ENDOSCOPIC SPINAL ACCESS SYSTEM


Device Classification Name

arthroscope

510(k) Number K991794
Device Name ENDOSCOPIC SPINAL ACCESS SYSTEM
Applicant
ENDIUS, INC.
23 west bacon st.
plainville, 
MA 
02762

Applicant Contact susan finneran
Correspondent
ENDIUS, INC.
23 west bacon st.
plainville, 
MA 
02762

Correspodent Contact susan finneran
Regulation Number 888.1100
Classification Product Code
HRX  
Date Received 05/26/1999
Decision Date 08/13/1999
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