The following data is part of a premarket notification filed by Spectra Medical Devices, Inc. with the FDA for Spectra-lor, 10 Ml Plastic Loss Of Resistance Syringe, L/s, Spectra-lor, 10ml Plastic Loss Of Resistance Syringe L/l.
| Device ID | K081524 |
| 510k Number | K081524 |
| Device Name: | SPECTRA-LOR, 10 ML PLASTIC LOSS OF RESISTANCE SYRINGE, L/S, SPECTRA-LOR, 10ML PLASTIC LOSS OF RESISTANCE SYRINGE L/L |
| Classification | Syringe, Piston |
| Applicant | SPECTRA MEDICAL DEVICES, INC. 4501 GREENDALE DRIVE Williamsburg, VA 23188 |
| Contact | Scott Henderson |
| Correspondent | Scott Henderson SPECTRA MEDICAL DEVICES, INC. 4501 GREENDALE DRIVE Williamsburg, VA 23188 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-02 |
| Decision Date | 2008-07-29 |
| Summary: | summary |