Device Classification Name |
Needle, Conduction, Anesthetic (W/Wo Introducer)
|
510(k) Number |
K150266 |
Device Name |
Remington Medical Inc. Tuohy Epidural Needles |
Applicant |
REMINGTON MEDICAL, INC. |
6830 MEADOWRIDGE COURT |
ALPHARETTA,
GA
30005
|
|
Applicant Contact |
CAITLIN SENTER |
Correspondent |
REMINGTON MEDICAL, INC. |
6830 MEADOWRIDGE COURT |
ALPHARETTA,
GA
30005
|
|
Correspondent Contact |
CAITLIN SENTER |
Regulation Number | 868.5150
|
Classification Product Code |
|
Date Received | 02/04/2015 |
Decision Date | 06/04/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|