Device Classification Name |
Catheter, Irrigation
|
510(k) Number |
K913539 |
Device Name |
THORACIC CATHTER STYLET |
Applicant |
INTL. MEDICAL DEVICES LTD. |
11845 WEST OLYMPIC BLVD. |
WESTSIDE TOWERS SUITE 1000 |
LOS ANGELES,
CA
90064
|
|
Applicant Contact |
JAY H GELLER |
Correspondent |
INTL. MEDICAL DEVICES LTD. |
11845 WEST OLYMPIC BLVD. |
WESTSIDE TOWERS SUITE 1000 |
LOS ANGELES,
CA
90064
|
|
Correspondent Contact |
JAY H GELLER |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 08/09/1991 |
Decision Date | 01/21/1992 |
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
|
|
|