Device Classification Name |
Needle, Conduction, Anesthetic (W/Wo Introducer)
|
510(k) Number |
K013610 |
Device Name |
PERIFIX SAFETY EPIDURAL NEEDLES |
Applicant |
B. BRAUN MEDICAL, INC. |
901 MARCON BLVD. |
ALLENTOWN,
PA
18109 -9341
|
|
Applicant Contact |
SHERI L MUSGNUNG |
Correspondent |
B. BRAUN MEDICAL, INC. |
901 MARCON BLVD. |
ALLENTOWN,
PA
18109 -9341
|
|
Correspondent Contact |
SHERI L MUSGNUNG |
Regulation Number | 868.5150
|
Classification Product Code |
|
Date Received | 11/05/2001 |
Decision Date | 01/25/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|