Device Classification Name |
guide, needle, surgical
|
510(k) Number |
K935538 |
Device Name |
BAUER TEMNO COAXIAL NEEDLE |
Applicant |
BAUER MEDICAL, INC. |
P.O. BOX 2010 |
PALM HARBOR,
FL
34682
|
|
Applicant Contact |
PATRICK J LAMB |
Correspondent |
BAUER MEDICAL, INC. |
P.O. BOX 2010 |
PALM HARBOR,
FL
34682
|
|
Correspondent Contact |
PATRICK J LAMB |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 11/16/1993 |
Decision Date | 02/22/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|