The following data is part of a premarket notification filed by Nestor Engineering Associates, Inc. with the FDA for Parallel Blade Marker.
| Device ID | K780991 |
| 510k Number | K780991 |
| Device Name: | PARALLEL BLADE MARKER |
| Classification | Knife, Surgical |
| Applicant | NESTOR ENGINEERING ASSOCIATES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EMF |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-14 |
| Decision Date | 1978-10-03 |