The following data is part of a premarket notification filed by Dyonics, Inc. with the FDA for Intra-articular Shaver.
| Device ID | K771218 |
| 510k Number | K771218 |
| Device Name: | INTRA-ARTICULAR SHAVER |
| Classification | Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment |
| Applicant | DYONICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KIJ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-07-05 |
| Decision Date | 1978-02-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010248756 | K771218 | 000 |