Device Classification Name |
apparatus, air handling, room
|
510(k) Number |
K923233 |
Device Name |
CARDIO-PAK LAPAROTOMY PACK |
Applicant |
CARDIO-MED-ASSOCIATES, INC. |
1602 4TH AVENUE NORTH |
BILLINGS,
MT
59101
|
|
Applicant Contact |
JEROME E DERNBACH |
Correspondent |
CARDIO-MED-ASSOCIATES, INC. |
1602 4TH AVENUE NORTH |
BILLINGS,
MT
59101
|
|
Correspondent Contact |
JEROME E DERNBACH |
Regulation Number | 878.5070
|
Classification Product Code |
|
Date Received | 07/01/1992 |
Decision Date | 03/20/1993 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|