The following data is part of a premarket notification filed by Nobles-lai Engineering, Inc. with the FDA for Noblescope Neuroendoscope System & Accessories.
| Device ID | K953554 |
| 510k Number | K953554 |
| Device Name: | NOBLESCOPE NEUROENDOSCOPE SYSTEM & ACCESSORIES |
| Classification | Endoscope, Neurological |
| Applicant | NOBLES-LAI ENGINEERING, INC. 17080 NEWHOPE ST. Fountain Valley, CA 92708 |
| Contact | Nancy E Shadforth |
| Correspondent | Nancy E Shadforth NOBLES-LAI ENGINEERING, INC. 17080 NEWHOPE ST. Fountain Valley, CA 92708 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-28 |
| Decision Date | 1995-10-18 |