The following data is part of a premarket notification filed by Blade Works, Inc. with the FDA for Bladeworks Disposable Alk Tubing.
| Device ID | K993591 |
| 510k Number | K993591 |
| Device Name: | BLADEWORKS DISPOSABLE ALK TUBING |
| Classification | Device, Irrigation, Ocular Surgery |
| Applicant | BLADE WORKS, INC. 30001 GOLDEN LANTERN #334 Laguna Niguel, CA 92677 |
| Contact | Gary Mocnik |
| Correspondent | Gary Mocnik BLADE WORKS, INC. 30001 GOLDEN LANTERN #334 Laguna Niguel, CA 92677 |
| Product Code | KYG |
| CFR Regulation Number | 886.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-22 |
| Decision Date | 1999-12-28 |