The following data is part of a premarket notification filed by Beijing Allgens Medical Science & Technology Co, L with the FDA for Bongold Bone Graft Material.
| Device ID | K141725 |
| 510k Number | K141725 |
| Device Name: | BONGOLD BONE GRAFT MATERIAL |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO, L 7 LIBERTY RIDGE ROAD Basking Ridge, NJ 07920 |
| Contact | Helen Cui |
| Correspondent | Helen Cui BEIJING ALLGENS MEDICAL SCIENCE & TECHNOLOGY CO, L 7 LIBERTY RIDGE ROAD Basking Ridge, NJ 07920 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-26 |
| Decision Date | 2015-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06953122702304 | K141725 | 000 |
| 06953122702168 | K141725 | 000 |
| 06953122702175 | K141725 | 000 |
| 06953122702182 | K141725 | 000 |
| 06953122702199 | K141725 | 000 |
| 06953122702205 | K141725 | 000 |
| 06953122702212 | K141725 | 000 |
| 06953122702236 | K141725 | 000 |
| 06953122702243 | K141725 | 000 |
| 06953122702250 | K141725 | 000 |
| 06953122702267 | K141725 | 000 |
| 06953122702274 | K141725 | 000 |
| 06953122702281 | K141725 | 000 |
| 06953122702298 | K141725 | 000 |
| 06953122702151 | K141725 | 000 |