The following data is part of a premarket notification filed by Neobiotech Co., Ltd. with the FDA for Sinus Quick It System.
| Device ID | K090527 |
| 510k Number | K090527 |
| Device Name: | SINUS QUICK IT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NEOBIOTECH CO., LTD. 13340E FIRESTONE BLVD. STE. J Sante Fe Springs, CA 90670 |
| Contact | Jung Bae Bang |
| Correspondent | Jung Bae Bang NEOBIOTECH CO., LTD. 13340E FIRESTONE BLVD. STE. J Sante Fe Springs, CA 90670 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-26 |
| Decision Date | 2009-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809486290231 | K090527 | 000 |
| 08809276761750 | K090527 | 000 |
| 08809276761767 | K090527 | 000 |
| 08809276761774 | K090527 | 000 |
| 08809276761781 | K090527 | 000 |
| 08809276761798 | K090527 | 000 |
| 08809276761804 | K090527 | 000 |
| 08809276761811 | K090527 | 000 |
| 08809276761637 | K090527 | 000 |
| 08809276761644 | K090527 | 000 |
| 08809276761651 | K090527 | 000 |
| 08809276761668 | K090527 | 000 |
| 08809276761675 | K090527 | 000 |
| 08809276761736 | K090527 | 000 |
| 08809276761743 | K090527 | 000 |