MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING

Device Classification Name

tubing, fluid delivery

510(k) Number

K131517

Device Name

MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING

Applicant

MEDRAD, INC. / BAYER MEDICAL CARE, INC.

one medrad dr.

indianola,
PA
15051

Applicant Contact

lisa a ewing

Correspondent

MEDRAD, INC. / BAYER MEDICAL CARE, INC.

one medrad dr.

indianola,
PA
15051

Correspodent Contact

lisa a ewing

Regulation Number

880.5440

Classification Product Code

FPK

Date Received

05/28/2013

Decision Date

08/02/2013

Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type

Special

Reviewed by Third Party

No

Combination Product

No