The following data is part of a premarket notification filed by Neobiotech Co., Ltd. with the FDA for Sinus Quick Eb System.
| Device ID | K090377 |
| 510k Number | K090377 |
| Device Name: | SINUS QUICK EB SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | NEOBIOTECH CO., LTD. 13340E FIRESTONE BLVD. STE. J Sante Fe Springs, CA 90670 |
| Contact | Jung B Bang |
| Correspondent | Jung B 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 | 2009-02-17 |
| Decision Date | 2009-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809276760067 | K090377 | 000 |
| 08809276760364 | K090377 | 000 |
| 08809276760371 | K090377 | 000 |
| 08809276760401 | K090377 | 000 |
| 08809276760418 | K090377 | 000 |
| 08809276760425 | K090377 | 000 |
| 08809276760432 | K090377 | 000 |
| 08809276760449 | K090377 | 000 |
| 08809276761828 | K090377 | 000 |
| 08809276760357 | K090377 | 000 |
| 08809276760340 | K090377 | 000 |
| 08809276760333 | K090377 | 000 |
| 08809276760074 | K090377 | 000 |
| 08809276760081 | K090377 | 000 |
| 08809276760098 | K090377 | 000 |
| 08809276760265 | K090377 | 000 |
| 08809276760272 | K090377 | 000 |
| 08809276760289 | K090377 | 000 |
| 08809276760296 | K090377 | 000 |
| 08809276760302 | K090377 | 000 |
| 08809276761835 | K090377 | 000 |
| 08809276761842 | K090377 | 000 |
| 08809276762061 | K090377 | 000 |
| 08809276762122 | K090377 | 000 |
| 08809276762139 | K090377 | 000 |
| 08809276762146 | K090377 | 000 |
| 08809276762153 | K090377 | 000 |
| 08809276762160 | K090377 | 000 |
| 08809276764225 | K090377 | 000 |
| 08809276765765 | K090377 | 000 |
| 08809276762054 | K090377 | 000 |
| 08809276762047 | K090377 | 000 |
| 08809276762030 | K090377 | 000 |
| 08809276761859 | K090377 | 000 |
| 08809276761866 | K090377 | 000 |
| 08809276761972 | K090377 | 000 |
| 08809276761989 | K090377 | 000 |
| 08809276761996 | K090377 | 000 |
| 08809276762009 | K090377 | 000 |
| 08809276762016 | K090377 | 000 |
| 08809276762023 | K090377 | 000 |
| 08809276769534 | K090377 | 000 |