The following data is part of a premarket notification filed by Acumed Instruments Corp. with the FDA for Burs For Micro Surgical Drill System.
| Device ID | K853658 |
| 510k Number | K853658 |
| Device Name: | BURS FOR MICRO SURGICAL DRILL SYSTEM |
| Classification | Bur, Surgical, General & Plastic Surgery |
| Applicant | ACUMED INSTRUMENTS CORP. 345 PUENTE DR. Santa Barbara, CA 93110 |
| Contact | Dave Esslinger |
| Correspondent | Dave Esslinger ACUMED INSTRUMENTS CORP. 345 PUENTE DR. Santa Barbara, CA 93110 |
| Product Code | GFF |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-03 |
| Decision Date | 1985-09-24 |