The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus B-5/b-7 Seriesballoon Catheter.
Device ID | K962925 |
510k Number | K962925 |
Device Name: | OLYMPUS B-5/B-7 SERIESBALLOON CATHETER |
Classification | Stents, Drains And Dilators For The Biliary Ducts |
Applicant | OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
Contact | Barry E Sands |
Correspondent | Barry E Sands OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
Product Code | FGE |
CFR Regulation Number | 876.5010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-29 |
Decision Date | 1996-10-25 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
14953170047487 | K962925 | 000 |
14953170047449 | K962925 | 000 |
14953170047371 | K962925 | 000 |
14953170463751 | K962925 | 000 |
14953170463706 | K962925 | 000 |
14953170463683 | K962925 | 000 |