The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Pr-23q Disposable Cannula (ball Tip).
| Device ID | K950729 |
| 510k Number | K950729 |
| Device Name: | OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP) |
| Classification | Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula |
| Applicant | OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success, NY 11042 -1179 |
| Contact | Barry Sands |
| Correspondent | Barry Sands OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success, NY 11042 -1179 |
| Product Code | ODD |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-16 |
| Decision Date | 1995-03-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170225007 | K950729 | 000 |
| 14953170154680 | K950729 | 000 |
| 14953170154659 | K950729 | 000 |
| 14953170154635 | K950729 | 000 |
| 14953170154604 | K950729 | 000 |
| 14953170154574 | K950729 | 000 |
| 14953170043885 | K950729 | 000 |
| 14953170043847 | K950729 | 000 |
| 14953170043762 | K950729 | 000 |
| 14953170043724 | K950729 | 000 |
| 14953170043601 | K950729 | 000 |
| 14953170043571 | K950729 | 000 |
| 14953170043175 | K950729 | 000 |
| 14953170043168 | K950729 | 000 |
| 04953170043130 | K950729 | 000 |
| 14953170154697 | K950729 | 000 |
| 14953170154703 | K950729 | 000 |
| 14953170154710 | K950729 | 000 |
| 14953170183833 | K950729 | 000 |
| 14953170183819 | K950729 | 000 |
| 14953170183796 | K950729 | 000 |
| 14953170183772 | K950729 | 000 |
| 14953170183758 | K950729 | 000 |
| 14953170183734 | K950729 | 000 |
| 14953170183710 | K950729 | 000 |
| 14953170183697 | K950729 | 000 |
| 14953170183635 | K950729 | 000 |
| 14953170183611 | K950729 | 000 |
| 14953170183574 | K950729 | 000 |
| 14953170183550 | K950729 | 000 |
| 14953170154734 | K950729 | 000 |
| 14953170154727 | K950729 | 000 |
| 14953170043113 | K950729 | 000 |