The following data is part of a premarket notification filed by Gainor Medical with the FDA for Ulster Scientific, Inc. Autolet Lancets/gainor Med.
| Device ID | K850150 |
| 510k Number | K850150 |
| Device Name: | ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED |
| Classification | Lancet, Blood |
| Applicant | GAINOR MEDICAL 12520 YELLOWHEAD TRAIL |
| Contact | Mark Gainor |
| Correspondent | Mark Gainor GAINOR MEDICAL 12520 YELLOWHEAD TRAIL |
| Product Code | FMK |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-14 |
| Decision Date | 1985-02-21 |