Device Classification Name |
Catheter, Conduction, Anesthetic
|
510(k) Number |
K981329 |
Device Name |
FETH-R-KATH |
Applicant |
EPIMED INTERNATIONAL, INC. |
P.O. BOX 1128 |
GLOVERSVILLE,
NY
12078
|
|
Applicant Contact |
DONALD HENDERSON |
Correspondent |
EPIMED INTERNATIONAL, INC. |
P.O. BOX 1128 |
GLOVERSVILLE,
NY
12078
|
|
Correspondent Contact |
DONALD HENDERSON |
Regulation Number | 868.5120
|
Classification Product Code |
|
Date Received | 04/13/1998 |
Decision Date | 08/26/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|