The following data is part of a premarket notification filed by Boehringer Laboratories with the FDA for Fluid Cooled Bone Saw Blade, 6000 Series.
| Device ID | K924953 |
| 510k Number | K924953 |
| Device Name: | FLUID COOLED BONE SAW BLADE, 6000 SERIES |
| Classification | Blade, Saw, General & Plastic Surgery, Surgical |
| Applicant | BOEHRINGER LABORATORIES P.O. BOX 870 Norristown, PA 19404 |
| Contact | John Karpowicz |
| Correspondent | John Karpowicz BOEHRINGER LABORATORIES P.O. BOX 870 Norristown, PA 19404 |
| Product Code | GFA |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-30 |
| Decision Date | 1993-01-21 |