X12 STERILE REFLECTIVE MARKER SPHERE


Device Classification Name

orthopedic stereotaxic instrument

510(k) Number K111443
Device Name X12 STERILE REFLECTIVE MARKER SPHERE
Applicant
PINSCO INC. DBA B & L ENGINEERING
1901 carnegie avenue
suite q
santa ana, 
CA 
92705

Applicant Contact lee a barnes
Correspondent
PINSCO INC. DBA B & L ENGINEERING
1901 carnegie avenue
suite q
santa ana, 
CA 
92705

Correspodent Contact lee a barnes
Regulation Number 882.4560
Classification Product Code
OLO  
Subsequent Product Code
HAW  
Date Received 05/24/2011
Decision Date 09/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No