The following data is part of a premarket notification filed by Aomori Olympus Co., Ltd. with the FDA for Mucus Collection Probe, Models Bc-401c & Bc-402c.
| Device ID | K022446 |
| 510k Number | K022446 |
| Device Name: | MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | AOMORI OLYMPUS CO., LTD. 2 CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler AOMORI OLYMPUS CO., LTD. 2 CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-25 |
| Decision Date | 2003-03-28 |
| Summary: | summary |