The following data is part of a premarket notification filed by Landos, Inc. with the FDA for Biostop G Bone Cement Restrictor.
| Device ID | K943727 |
| 510k Number | K943727 |
| Device Name: | BIOSTOP G BONE CEMENT RESTRICTOR |
| Classification | Cement Obturator |
| Applicant | LANDOS, INC. STE 1, 301 LINDENWOOD DR. OFFICE 26 Malvern, PA 19355 |
| Contact | Jerome Veron |
| Correspondent | Jerome Veron LANDOS, INC. STE 1, 301 LINDENWOOD DR. OFFICE 26 Malvern, PA 19355 |
| Product Code | LZN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-02 |
| Decision Date | 1995-05-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295174592 | K943727 | 000 |
| 10603295174585 | K943727 | 000 |
| 10603295174578 | K943727 | 000 |
| 10603295174561 | K943727 | 000 |
| 10603295174554 | K943727 | 000 |
| 10603295174547 | K943727 | 000 |