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 |