AMBIT TUNNELER


Device Classification Name

catheter, conduction, anesthetic

510(k) Number K110814
Device Name AMBIT TUNNELER
Applicant
SUMMIT MEDICAL PRODUCTS, INC
2480 south main street
#212
salt lake city, 
UT 
84118

Applicant Contact marko v amen
Regulation Number 868.5120
Classification Product Code
BSO  
Date Received 03/24/2011
Decision Date 04/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Abbreviated
Reviewed by Third Party Yes

Combination Product

No