The following data is part of a premarket notification filed by Sable Industries with the FDA for Sable Blades.
| Device ID | K863885 |
| 510k Number | K863885 |
| Device Name: | SABLE BLADES |
| Classification | Blade, Scalpel |
| Applicant | SABLE INDUSTRIES COLLEGE PLAZA, P.O. BOX 6242 Oceanside, CA 92056 |
| Contact | Dimitri G Mondiadis |
| Correspondent | Dimitri G Mondiadis SABLE INDUSTRIES COLLEGE PLAZA, P.O. BOX 6242 Oceanside, CA 92056 |
| Product Code | GES |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-06 |
| Decision Date | 1986-10-24 |