The following data is part of a premarket notification filed by Nuell Air Equipment & Hospital Supplies, Inc. with the FDA for Surgical Burs.
| Device ID | K880706 |
| 510k Number | K880706 |
| Device Name: | SURGICAL BURS |
| Classification | Bur, Surgical, General & Plastic Surgery |
| Applicant | NUELL AIR EQUIPMENT & HOSPITAL SUPPLIES, INC. P.O. BOX 55 Warsaw, IN 46581 -0055 |
| Contact | Darlene Holsclaw |
| Correspondent | Darlene Holsclaw NUELL AIR EQUIPMENT & HOSPITAL SUPPLIES, INC. P.O. BOX 55 Warsaw, IN 46581 -0055 |
| Product Code | GFF |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-22 |
| Decision Date | 1988-02-26 |