The following data is part of a premarket notification filed by Arthronet Medical, Inc. with the FDA for Arthronet Blackline 2 And 3 Piece Arthroscopic Blades, Models 123, 133, 153, 163, 173 And 183.
| Device ID | K023777 |
| 510k Number | K023777 |
| Device Name: | ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153, 163, 173 AND 183 |
| Classification | Arthroscope |
| Applicant | ARTHRONET MEDICAL, INC. 8 HAMMOND, SUITE 108 Irvine, CA 92618 |
| Contact | Carolina Schaber |
| Correspondent | Carolina Schaber ARTHRONET MEDICAL, INC. 8 HAMMOND, SUITE 108 Irvine, CA 92618 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-12 |
| Decision Date | 2002-12-11 |
| Summary: | summary |