The following data is part of a premarket notification filed by Surgical Specialties Corp. with the FDA for Sharpoint Ultraplug Extended Wear Plug.
| Device ID | K020882 |
| 510k Number | K020882 |
| Device Name: | SHARPOINT ULTRAPLUG EXTENDED WEAR PLUG |
| Classification | Plug, Punctum |
| Applicant | SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading, PA 19606 |
| Contact | Elizabeth Lazaro |
| Correspondent | Elizabeth Lazaro SURGICAL SPECIALTIES CORP. 100 DENNIS DR. Reading, PA 19606 |
| 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 | 2002-03-18 |
| Decision Date | 2002-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841668114773 | K020882 | 000 |
| 10848782023810 | K020882 | 000 |
| 10848782023827 | K020882 | 000 |
| 10848782024091 | K020882 | 000 |
| 00851807007200 | K020882 | 000 |
| 00851807007217 | K020882 | 000 |
| 00851807007224 | K020882 | 000 |
| 00851807007231 | K020882 | 000 |
| 00841668114759 | K020882 | 000 |
| 00841668114766 | K020882 | 000 |
| 10848782023803 | K020882 | 000 |