The following data is part of a premarket notification filed by New Business Development, Llc with the FDA for Nbd Cement Restrictor Device.
| Device ID | K021788 |
| 510k Number | K021788 |
| Device Name: | NBD CEMENT RESTRICTOR DEVICE |
| Classification | Prosthesis, Hip, Cement Restrictor |
| Applicant | NEW BUSINESS DEVELOPMENT, LLC 605 INDUSTRIAL COURT Woodstock, GA 30189 |
| Contact | Tim B Lusby |
| Correspondent | Tim B Lusby NEW BUSINESS DEVELOPMENT, LLC 605 INDUSTRIAL COURT Woodstock, GA 30189 |
| Product Code | JDK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-31 |
| Decision Date | 2002-10-04 |
| Summary: | summary |