The following data is part of a premarket notification filed by Ulster Scientific, Inc. with the FDA for Feather-touch Single-stick Device.
| Device ID | K942620 |
| 510k Number | K942620 |
| Device Name: | FEATHER-TOUCH SINGLE-STICK DEVICE |
| Classification | Lancet, Blood |
| Applicant | ULSTER SCIENTIFIC, INC. P.O. BOX 819 New Paltz, NY 12561 -0819 |
| Contact | Daniel A Graff |
| Correspondent | Daniel A Graff ULSTER SCIENTIFIC, INC. P.O. BOX 819 New Paltz, NY 12561 -0819 |
| Product Code | FMK |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-02 |
| Decision Date | 1994-06-22 |