The following data is part of a premarket notification filed by Ds Mfg., Inc. with the FDA for Bone Graft Harvester.
| Device ID | K973560 |
| 510k Number | K973560 |
| Device Name: | BONE GRAFT HARVESTER |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | DS MFG., INC. 10605 STEAMBOAT LANDING Columbia, MD 21044 |
| Contact | Martin A Yahiro, M.d. |
| Correspondent | Martin A Yahiro, M.d. DS MFG., INC. 10605 STEAMBOAT LANDING Columbia, MD 21044 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-19 |
| Decision Date | 1997-11-12 |