The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Calcium Sulfate Pellets.
| Device ID | K001559 |
| 510k Number | K001559 |
| Device Name: | CALCIUM SULFATE PELLETS |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Contact | Karen Ariemma |
| Correspondent | Karen Ariemma HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-19 |
| Decision Date | 2000-06-20 |