The following data is part of a premarket notification filed by Olympus Optical Co., Ltd. with the FDA for Olympus Xcyf-tp3 Cystofiberscope/nephrofiberscope.
Device ID | K032092 |
510k Number | K032092 |
Device Name: | OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE |
Classification | Forceps, Biopsy, Non-electric |
Applicant | OLYMPUS OPTICAL CO., LTD. 34-3 HIRAI HINODE-MACHI, Nishitima-gun, Tokyo, JP 190-0182 |
Contact | Masao Wada |
Correspondent | Derwyn Reuber INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
Product Code | FCL |
Subsequent Product Code | FAJ |
Subsequent Product Code | FDI |
Subsequent Product Code | FGA |
Subsequent Product Code | KGE |
Subsequent Product Code | KNS |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2003-07-07 |
Decision Date | 2003-07-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04953170339424 | K032092 | 000 |
04953170339417 | K032092 | 000 |
04953170328817 | K032092 | 000 |
04953170292521 | K032092 | 000 |
04953170292323 | K032092 | 000 |
04953170286964 | K032092 | 000 |
04953170411182 | K032092 | 000 |
04953170411144 | K032092 | 000 |