LIGHTY DD INFUSION SET


Device Classification Name

set, administration, intravascular

510(k) Number K110282
Device Name LIGHTY DD INFUSION SET
Applicant
MEDX-SET LTD
56b shawdow dr.
hudson, 
NH 
03051

Applicant Contact raymond kelly
Correspondent
MEDX-SET LTD
56b shawdow dr.
hudson, 
NH 
03051

Correspodent Contact raymond kelly
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 01/31/2011
Decision Date 04/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No