The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject(r) Monolettor Safety Lancet.
| Device ID | K932785 |
| 510k Number | K932785 |
| Device Name: | MONOJECT(R) MONOLETTOR SAFETY LANCET |
| Classification | Lancet, Blood |
| Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Contact | Dennis Pozzo |
| Correspondent | Dennis Pozzo SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
| Product Code | FMK |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-09 |
| Decision Date | 1993-09-29 |