The following data is part of a premarket notification filed by Cardio-med-associates, Inc. with the FDA for Cardio-pak Laparotomy Pack.
| Device ID | K923233 |
| 510k Number | K923233 |
| Device Name: | CARDIO-PAK LAPAROTOMY PACK |
| Classification | Apparatus, Air Handling, Room |
| Applicant | CARDIO-MED-ASSOCIATES, INC. 1602 4TH AVENUE NORTH Billings, MT 59101 |
| Contact | Jerome E Dernbach |
| Correspondent | Jerome E Dernbach CARDIO-MED-ASSOCIATES, INC. 1602 4TH AVENUE NORTH Billings, MT 59101 |
| Product Code | FZH |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-01 |
| Decision Date | 1993-03-20 |