The following data is part of a premarket notification filed by Spectra, Inc. with the FDA for Spectra Medical Safety Scapel.
| Device ID | K091462 |
| 510k Number | K091462 |
| Device Name: | SPECTRA MEDICAL SAFETY SCAPEL |
| Classification | Handle, Scalpel |
| Applicant | SPECTRA, INC. 260 F&H FORDHAM ROAD Wilmington, MA 01887 |
| Contact | Agustin Turriza |
| Correspondent | Agustin Turriza SPECTRA, INC. 260 F&H FORDHAM ROAD Wilmington, MA 01887 |
| Product Code | GDZ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-18 |
| Decision Date | 2009-12-15 |