The following data is part of a premarket notification filed by Medennium, Inc. with the FDA for Smart Plug, Model 500; Smartplug Forceps, Model 502; Push Rod, Model 503.
| Device ID | K022043 |
| 510k Number | K022043 |
| Device Name: | SMART PLUG, MODEL 500; SMARTPLUG FORCEPS, MODEL 502; PUSH ROD, MODEL 503 |
| Classification | Plug, Punctum |
| Applicant | MEDENNIUM, INC. 15350 BARRANCA PKWY. Irvine, CA 92618 |
| Contact | Julian Abadia |
| Correspondent | Julian Abadia MEDENNIUM, INC. 15350 BARRANCA PKWY. Irvine, CA 92618 |
| Product Code | LZU |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-24 |
| Decision Date | 2002-10-18 |