The following data is part of a premarket notification filed by Ulster Scientific, Inc. with the FDA for Neonatal Unilet.
| Device ID | K861243 |
| 510k Number | K861243 |
| Device Name: | NEONATAL UNILET |
| Classification | Lancet, Blood |
| Applicant | ULSTER SCIENTIFIC, INC. P.O. BOX 902 Highland, NY 12528 |
| Contact | Robert K Mcewen |
| Correspondent | Robert K Mcewen ULSTER SCIENTIFIC, INC. P.O. BOX 902 Highland, NY 12528 |
| Product Code | FMK |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-02 |
| Decision Date | 1986-04-29 |