The following data is part of a premarket notification filed by Longtek Scientific Co., Ltd. with the FDA for Cenefom Pva Surgical Spear.
| Device ID | K082460 |
| 510k Number | K082460 |
| Device Name: | CENEFOM PVA SURGICAL SPEAR |
| Classification | Sponge, Ophthalmic |
| Applicant | LONGTEK SCIENTIFIC CO., LTD. 7128 STAFFORDSHIRE ST. Houston, TX 77030 |
| Contact | Joseph J Chang |
| Correspondent | Joseph J Chang LONGTEK SCIENTIFIC CO., LTD. 7128 STAFFORDSHIRE ST. Houston, TX 77030 |
| Product Code | HOZ |
| CFR Regulation Number | 886.4790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-26 |
| Decision Date | 2008-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04711552929782 | K082460 | 000 |
| 00840516113760 | K082460 | 000 |
| 00840516113784 | K082460 | 000 |
| 00840516113807 | K082460 | 000 |
| 00840516113821 | K082460 | 000 |
| 00840516113692 | K082460 | 000 |
| 04711552920352 | K082460 | 000 |
| 04711552929683 | K082460 | 000 |
| 04711552929751 | K082460 | 000 |
| 00840516113746 | K082460 | 000 |