The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Urf-p2 Ureterorenofiberscope/choledochofiberscope.
Device ID | K912120 |
510k Number | K912120 |
Device Name: | URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE |
Classification | Choledochoscope And Accessories, Flexible/rigid |
Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
Contact | Daniel J Dillon |
Correspondent | Daniel J Dillon OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
Product Code | FBN |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-05-14 |
Decision Date | 1991-08-07 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
14953170375078 | K912120 | 000 |
04953170058950 | K912120 | 000 |
04953170061516 | K912120 | 000 |
04953170063114 | K912120 | 000 |
04953170069048 | K912120 | 000 |
04953170286988 | K912120 | 000 |
04953170316593 | K912120 | 000 |
04953170340154 | K912120 | 000 |
04953170340307 | K912120 | 000 |
14953170375054 | K912120 | 000 |