PENCAN SPINAL NEEDLE


Device Classification Name

needle, conduction, anesthetic (w/wo introducer)

510(k) Number K112515
Device Name PENCAN SPINAL NEEDLE
Applicant
B. BRAUN MEDICAL, INC.
901 marcon blvd.
allentown, 
PA 
18109 -9341

Applicant Contact lisa giaquinto
Correspondent
B. BRAUN MEDICAL, INC.
901 marcon blvd.
allentown, 
PA 
18109 -9341

Correspodent Contact lisa giaquinto
Regulation Number 868.5150
Classification Product Code
BSP  
Date Received 08/30/2011
Decision Date 12/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No