The following data is part of a premarket notification filed by Olympus Optical Co., Ltd. with the FDA for Mss-28cs-301/701 Needlescope.
| Device ID | K013759 |
| 510k Number | K013759 |
| Device Name: | MSS-28CS-301/701 NEEDLESCOPE |
| Classification | Endoscope, Neurological |
| Applicant | OLYMPUS OPTICAL CO., LTD. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS OPTICAL CO., LTD. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | GWG |
| CFR Regulation Number | 882.1480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-13 |
| Decision Date | 2002-08-20 |
| Summary: | summary |