The following data is part of a premarket notification filed by Olympus Optical Co., Ltd. with the FDA for Olympus Ultrasonic Gastrovideoscope Gf Type Uc140p-do5 & Olympus Ultrasonic Gastrofiberscope Gf Type Uc30p.
| Device ID | K021886 |
| 510k Number | K021886 |
| Device Name: | OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLYMPUS ULTRASONIC GASTROFIBERSCOPE GF TYPE UC30P |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | OLYMPUS OPTICAL CO., LTD. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Mark Job TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2002-06-07 |
| Decision Date | 2002-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170356223 | K021886 | 000 |
| 04953170356209 | K021886 | 000 |
| 04953170356056 | K021886 | 000 |
| 04953170355943 | K021886 | 000 |
| 04953170328428 | K021886 | 000 |
| 04953170063817 | K021886 | 000 |
| 04953170062209 | K021886 | 000 |
| 04953170062063 | K021886 | 000 |