The following data is part of a premarket notification filed by Disk Whisk, Inc. with the FDA for Disk Whisk Cutting Device (conical, Elliptical And Ball Head).
| Device ID | K971342 |
| 510k Number | K971342 |
| Device Name: | DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD) |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | DISK WHISK, INC. 600 SOUTH RANCHO LN., STE. 113 Las Vegas, NV 89106 |
| Contact | Rick D Roberts |
| Correspondent | Rick D Roberts DISK WHISK, INC. 600 SOUTH RANCHO LN., STE. 113 Las Vegas, NV 89106 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-10 |
| Decision Date | 1997-07-08 |