The following data is part of a premarket notification filed by Ammex Cardiopulmonary Corp. with the FDA for Ammex Tubing Organizer.
| Device ID | K934782 |
| 510k Number | K934782 |
| Device Name: | AMMEX TUBING ORGANIZER |
| Classification | Accessory Equipment, Cardiopulmonary Bypass |
| Applicant | AMMEX CARDIOPULMONARY CORP. 221 NORFOLK SUITE 508 Houston, TX 77098 |
| Contact | Hillard E Miller Iii |
| Correspondent | Hillard E Miller Iii AMMEX CARDIOPULMONARY CORP. 221 NORFOLK SUITE 508 Houston, TX 77098 |
| Product Code | KRI |
| CFR Regulation Number | 870.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-06 |
| Decision Date | 1993-11-18 |