The following data is part of a premarket notification filed by The Olympus Optical Co. with the FDA for Disposable Bending Cannula Pr-233q.
| Device ID | K011149 |
| 510k Number | K011149 |
| Device Name: | DISPOSABLE BENDING CANNULA PR-233Q |
| Classification | Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula |
| Applicant | THE OLYMPUS OPTICAL CO. ENDOSCOPE DIVISION TWO CORPORATE CENTER DRIVE Melville, NY 11747 -3157 |
| Contact | Laura Stoms-tyler |
| Correspondent | Laura Stoms-tyler THE OLYMPUS OPTICAL CO. ENDOSCOPE DIVISION TWO CORPORATE CENTER DRIVE Melville, NY 11747 -3157 |
| Product Code | ODD |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-16 |
| Decision Date | 2001-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170044240 | K011149 | 000 |