Device Classification Name |
catheter, conduction, anesthetic
|
510(k) Number |
K971851 |
Device Name |
INTERPLEURAL ANESTHESIA CATHETER |
Applicant |
AXIOM MEDICAL, INC. |
555 WEST VICTORIA ST. |
RANCHO DOMINGUEZ,
CA
90220
|
|
Applicant Contact |
RIDWAN HARDY |
Correspondent |
AXIOM MEDICAL, INC. |
555 WEST VICTORIA ST. |
RANCHO DOMINGUEZ,
CA
90220
|
|
Correspondent Contact |
RIDWAN HARDY |
Regulation Number | 868.5120
|
Classification Product Code |
|
Date Received | 05/20/1997 |
Decision Date | 01/22/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|