The following data is part of a premarket notification filed by Adven Medical with the FDA for Re-sharpenable Saw Blades.
| Device ID | K940501 |
| 510k Number | K940501 |
| Device Name: | RE-SHARPENABLE SAW BLADES |
| Classification | Blade, Saw, General & Plastic Surgery, Surgical |
| Applicant | ADVEN MEDICAL 3750 PILGRIM LN. Plymouth, MN 55441 |
| Contact | Mark W Aldana |
| Correspondent | Mark W Aldana ADVEN MEDICAL 3750 PILGRIM LN. Plymouth, MN 55441 |
| Product Code | GFA |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-02 |
| Decision Date | 1994-06-28 |