The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Artus Disposable Sheaths/cutters.
| Device ID | K880881 |
| 510k Number | K880881 |
| Device Name: | ARTUS DISPOSABLE SHEATHS/CUTTERS |
| Classification | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/attachment |
| Applicant | ACUFEX MICROSURGICAL, INC. 575 UNIVERSITY AVE. Norwood, MA 02062 |
| Contact | Richard E Franko |
| Correspondent | Richard E Franko ACUFEX MICROSURGICAL, INC. 575 UNIVERSITY AVE. Norwood, MA 02062 |
| Product Code | HSZ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-02 |
| Decision Date | 1988-05-04 |