The following data is part of a premarket notification filed by Spectra Medical Devices, Inc. with the FDA for Spectra-glass Lor (loss Of Resistance Syringe, 5cc Metal L/s Or L/l Tip, Spectra-glass Lor (loss Of Resistance) Syringe.
| Device ID | K082674 |
| 510k Number | K082674 |
| Device Name: | SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE |
| Classification | Syringe, Piston |
| Applicant | SPECTRA MEDICAL DEVICES, INC. 260-F FORDHAM RD Wilmington, MA 01887 |
| Contact | Scott Henderson |
| Correspondent | Scott Henderson SPECTRA MEDICAL DEVICES, INC. 260-F FORDHAM RD Wilmington, MA 01887 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-15 |
| Decision Date | 2008-11-28 |