The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Bml Series.
| Device ID | K903529 |
| 510k Number | K903529 |
| Device Name: | BML SERIES |
| Classification | Lithotriptor, Biliary Mechanical |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Daniel J Dillon |
| Correspondent | Daniel J Dillon OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | LQC |
| CFR Regulation Number | 876.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-06 |
| Decision Date | 1991-01-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04953170218446 | K903529 | 000 |
| 14953170032988 | K903529 | 000 |
| 04953170032967 | K903529 | 000 |
| 04953170032943 | K903529 | 000 |
| 14953170032872 | K903529 | 000 |
| 04953170032851 | K903529 | 000 |
| 04953170032837 | K903529 | 000 |
| 14953170032766 | K903529 | 000 |
| 14953170032742 | K903529 | 000 |
| 04953170033001 | K903529 | 000 |
| 04953170033025 | K903529 | 000 |
| 14953170218429 | K903529 | 000 |
| 14953170218412 | K903529 | 000 |
| 14953170218399 | K903529 | 000 |
| 14953170218382 | K903529 | 000 |
| 14953170218368 | K903529 | 000 |
| 14953170218344 | K903529 | 000 |
| 04953170033247 | K903529 | 000 |
| 14953170033077 | K903529 | 000 |
| 04953170032721 | K903529 | 000 |