Device Classification Name |
needle, conduction, anesthetic (w/wo introducer)
|
510(k) Number |
K133632 |
Device Name |
PERICAN ULTRA |
Applicant |
B.BRAUN MEDICAL, INC |
901 MARCON BLVD |
ALLENTOWN,
PA
18109 -4962
|
|
Applicant Contact |
LISA GIAQUINTO |
Correspondent |
B.BRAUN MEDICAL, INC |
901 MARCON BLVD |
ALLENTOWN,
PA
18109 -4962
|
|
Correspondent Contact |
LISA GIAQUINTO |
Regulation Number | 868.5150
|
Classification Product Code |
|
Date Received | 11/26/2013 |
Decision Date | 06/27/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|