VIALOK NON-VENTED


Device Classification Name

set, i.v. fluid transfer

510(k) Number K121182
Device Name VIALOK NON-VENTED
Applicant
YUKON MEDICAL, LLC
4819-400 emperor blvd
durham, 
NC 
27703

Applicant Contact carl dupper
Regulation Number 880.5440
Classification Product Code
LHI  
Date Received 04/18/2012
Decision Date 05/03/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No