The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Chp-p10 Nephroscope/cystoscope.
| Device ID | K843084 |
| 510k Number | K843084 |
| Device Name: | OLYMPUS CHP-P10 NEPHROSCOPE/CYSTOSCOPE |
| Classification | Cystourethroscope |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Scott J Solano |
| Correspondent | Scott J Solano OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | FBO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-06 |
| Decision Date | 1985-01-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170367809 | K843084 | 000 |
| 04953170359958 | K843084 | 000 |
| 04953170213489 | K843084 | 000 |
| 04953170064623 | K843084 | 000 |
| 04953170063909 | K843084 | 000 |
| 04953170451980 | K843084 | 000 |