The following data is part of a premarket notification filed by Dalton Technology, Inc. with the FDA for Modular Flexible Drilling System.
| Device ID | K901165 |
| 510k Number | K901165 |
| Device Name: | MODULAR FLEXIBLE DRILLING SYSTEM |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | DALTON TECHNOLOGY, INC. 6062 SAN FERNANDO RD. Glendale, CA 91202 |
| Contact | James Lafferty |
| Correspondent | James Lafferty DALTON TECHNOLOGY, INC. 6062 SAN FERNANDO RD. Glendale, CA 91202 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-13 |
| Decision Date | 1990-06-13 |