Device Classification Name |
catheter, conduction, anesthetic
|
510(k) Number |
K884969 |
Device Name |
BIO-MATE(TM) EPIDURAL CATHETER |
Applicant |
MEDEVICE, INC. |
5080 TIMBERLEA BLVD. |
UNIT 11, MISSISSAUGA, ONTARIO |
CANADA L4W 4M2,
CA
|
|
Applicant Contact |
RALPH D MANDELL |
Correspondent |
MEDEVICE, INC. |
5080 TIMBERLEA BLVD. |
UNIT 11, MISSISSAUGA, ONTARIO |
CANADA L4W 4M2,
CA
|
|
Correspondent Contact |
RALPH D MANDELL |
Regulation Number | 868.5120
|
Classification Product Code |
|
Date Received | 11/30/1988 |
Decision Date | 06/23/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|