The following data is part of a premarket notification filed by Oasis Medical, Inc. with the FDA for Soft Plug Absorbable Plug-sa.
| Device ID | K013613 |
| 510k Number | K013613 |
| Device Name: | SOFT PLUG ABSORBABLE PLUG-SA |
| Classification | Plug, Punctum |
| Applicant | OASIS MEDICAL, INC. 514 S. VERMONT AVE. Glendora, CA 91741 |
| Contact | James Christensen |
| Correspondent | James Christensen OASIS MEDICAL, INC. 514 S. VERMONT AVE. Glendora, CA 91741 |
| 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 | 2001-11-05 |
| Decision Date | 2002-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00886158015284 | K013613 | 000 |
| 00886158015277 | K013613 | 000 |
| 00886158015260 | K013613 | 000 |
| 00886158015253 | K013613 | 000 |
| 00886158015246 | K013613 | 000 |