The following data is part of a premarket notification filed by Transidyne General Corp. with the FDA for 1420 Heel-stick(tm) Neonatal Blood Sampling Kit.
| Device ID | K895202 |
| 510k Number | K895202 |
| Device Name: | 1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT |
| Classification | General Surgery Tray |
| Applicant | TRANSIDYNE GENERAL CORP. 3711 PLAZA DR., #4 Ann Arbor, MI 48108 |
| Contact | Margaret K Beaudet |
| Correspondent | Margaret K Beaudet TRANSIDYNE GENERAL CORP. 3711 PLAZA DR., #4 Ann Arbor, MI 48108 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-18 |
| Decision Date | 1989-09-15 |