The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Lus Ultrasonic Lithotripter.
| Device ID | K873367 |
| 510k Number | K873367 |
| Device Name: | OLYMPUS LUS ULTRASONIC LITHOTRIPTER |
| Classification | Lithotriptor, Ultrasonic |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Joseph R Williams |
| Correspondent | Joseph R Williams OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | FEO |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-21 |
| Decision Date | 1987-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170157165 | K873367 | 000 |
| 04953170157134 | K873367 | 000 |
| 04953170138560 | K873367 | 000 |
| 04953170138553 | K873367 | 000 |
| 04953170138546 | K873367 | 000 |
| 04953170026737 | K873367 | 000 |
| 04953170026799 | K873367 | 000 |
| 04953170318818 | K873367 | 000 |
| 04953170026782 | K873367 | 000 |