The following data is part of a premarket notification filed by Staar Surgical Co. with the FDA for Foam Tip Injector.
| Device ID | K980696 |
| 510k Number | K980696 |
| Device Name: | FOAM TIP INJECTOR |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | STAAR SURGICAL CO. 1911 WALKER AVE. Monrovia, CA 91016 |
| Contact | Janice L Filippelli |
| Correspondent | Janice L Filippelli STAAR SURGICAL CO. 1911 WALKER AVE. Monrovia, CA 91016 |
| Product Code | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-23 |
| Decision Date | 1998-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840311300020 | K980696 | 000 |
| 00840311300013 | K980696 | 000 |
| 10840311300027 | K980696 | 000 |
| 10840311300010 | K980696 | 000 |
| 00840311344802 | K980696 | 000 |