The following data is part of a premarket notification filed by Olympus Optical Co., Ltd. with the FDA for Lf-dp Gastrointestinal And Sigmoid Fiberscope, Accessories And Ancillary Equipment.
| Device ID | K002231 |
| 510k Number | K002231 |
| Device Name: | LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY EQUIPMENT |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| 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 | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-24 |
| Decision Date | 2001-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170156229 | K002231 | 000 |
| 04953170023804 | K002231 | 000 |
| 04953170024467 | K002231 | 000 |
| 04953170024474 | K002231 | 000 |
| 04953170136894 | K002231 | 000 |
| 04953170136917 | K002231 | 000 |
| 04953170028083 | K002231 | 000 |
| 04953170063350 | K002231 | 000 |
| 04953170064104 | K002231 | 000 |
| 04953170064111 | K002231 | 000 |
| 04953170064319 | K002231 | 000 |
| 04953170078781 | K002231 | 000 |
| 04953170155017 | K002231 | 000 |
| 04953170023729 | K002231 | 000 |