DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR


Device Classification Name

needle, conduction, anesthetic (w/wo introducer)

510(k) Number K073516
Device Name DISCYPHOR DIRECT CATHETER SYSTEM, DISCYPHOR DIRECT NEEDLES, LONG, DISCYPHOR DIRECT NEEDLES, REGULAR
Applicant
KYPHON, INC.
1221 crossman ave.
sunnyvale, 
CA 
94089

Applicant Contact pamela segale
Correspondent
KYPHON, INC.
1221 crossman ave.
sunnyvale, 
CA 
94089

Correspodent Contact pamela segale
Regulation Number 868.5150
Classification Product Code
BSP  
Date Received 12/14/2007
Decision Date 02/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No