The following data is part of a premarket notification filed by Transidyne General Corp. with the FDA for Model 1050 - Umbilical Cord Blood Sampling Kit.
| Device ID | K897133 |
| 510k Number | K897133 |
| Device Name: | MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT |
| Classification | Arterial Blood Sampling Kit |
| Applicant | TRANSIDYNE GENERAL CORP. 3711 PLAZA DR., #4 Ann Arbor, MI 48108 |
| Contact | K Beaudet |
| Correspondent | K Beaudet TRANSIDYNE GENERAL CORP. 3711 PLAZA DR., #4 Ann Arbor, MI 48108 |
| Product Code | CBT |
| CFR Regulation Number | 868.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-27 |
| Decision Date | 1990-03-30 |