The following data is part of a premarket notification filed by Olympus Optical Co., Ltd. with the FDA for Olympus Injector Nm-4-1, Nm-5-1, Nm-6-1, Nm-7-1, Nm-8-1, Nm-9-1.
| Device ID | K011484 |
| 510k Number | K011484 |
| Device Name: | OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1 |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| 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 | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-14 |
| Decision Date | 2001-08-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170034012 | K011484 | 000 |
| 14953170033589 | K011484 | 000 |
| 14953170033657 | K011484 | 000 |
| 14953170033718 | K011484 | 000 |
| 14953170033770 | K011484 | 000 |
| 04953170033810 | K011484 | 000 |
| 14953170033862 | K011484 | 000 |
| 14953170033930 | K011484 | 000 |
| 04953170033971 | K011484 | 000 |
| 04953170033537 | K011484 | 000 |