The following data is part of a premarket notification filed by Bio Medical Devices, Inc. with the FDA for Bio-prep Cement Restrictor.
| Device ID | K931847 |
| 510k Number | K931847 |
| Device Name: | BIO-PREP CEMENT RESTRICTOR |
| Classification | Cement Obturator |
| Applicant | BIO MEDICAL DEVICES, INC. 1752 A LANGLEY AVE. Irvine, CA 92714 |
| Contact | Nick Herbert |
| Correspondent | Nick Herbert BIO MEDICAL DEVICES, INC. 1752 A LANGLEY AVE. Irvine, CA 92714 |
| Product Code | LZN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-13 |
| Decision Date | 1994-06-28 |