The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Tjf-140r/jf-140r Evis Duodenovideoscopes And Accessories, Olympus Maj-311/maj-411 Distal Covers.
Device ID | K980465 |
510k Number | K980465 |
Device Name: | OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS |
Classification | Duodenoscope And Accessories, Flexible/rigid |
Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
Contact | Laura Storms-tayler |
Correspondent | Laura Storms-tayler OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
Product Code | FDT |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-02-05 |
Decision Date | 1998-04-21 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
14953170368612 | K980465 | 000 |
04953170339851 | K980465 | 000 |
14953170194648 | K980465 | 000 |
04953170071416 | K980465 | 000 |