The following data is part of a premarket notification filed by Implant Technology, Inc. with the FDA for Implant Technology Bone Cement Extractor.
| Device ID | K891472 |
| 510k Number | K891472 |
| Device Name: | IMPLANT TECHNOLOGY BONE CEMENT EXTRACTOR |
| Classification | System, Cement Removal Extraction |
| Applicant | IMPLANT TECHNOLOGY, INC. 400 PLAZA DR. Secaucus, NJ 07094 |
| Contact | Peter J Scranton |
| Correspondent | Peter J Scranton IMPLANT TECHNOLOGY, INC. 400 PLAZA DR. Secaucus, NJ 07094 |
| Product Code | LZV |
| CFR Regulation Number | 888.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-15 |
| Decision Date | 1989-05-02 |