The following data is part of a premarket notification filed by Advanced Vision Science with the FDA for Surgidev Silicone Punctum Plug.
| Device ID | K980844 |
| 510k Number | K980844 |
| Device Name: | SURGIDEV SILICONE PUNCTUM PLUG |
| Classification | Plug, Punctum |
| Applicant | ADVANCED VISION SCIENCE 5743 THORNWOOD DR. Goleta, CA 93117 |
| Contact | Khalid Mentak |
| Correspondent | Khalid Mentak ADVANCED VISION SCIENCE 5743 THORNWOOD DR. Goleta, CA 93117 |
| 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 | 1998-03-04 |
| Decision Date | 1998-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10848782023872 | K980844 | 000 |
| 10848782023865 | K980844 | 000 |
| 10848782023858 | K980844 | 000 |
| 10848782023841 | K980844 | 000 |
| 10848782023834 | K980844 | 000 |