The following data is part of a premarket notification filed by Gwowei Technology Co., Ltd. with the FDA for Wellgraft Pe Ii.
| Device ID | K072170 |
| 510k Number | K072170 |
| Device Name: | WELLGRAFT PE II |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | GWOWEI TECHNOLOGY CO., LTD. 2904 N. BOLDT DRIVE Flagstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich GWOWEI TECHNOLOGY CO., LTD. 2904 N. BOLDT DRIVE Flagstaff, AZ 86001 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2007-08-06 |
| Decision Date | 2008-04-04 |
| Summary: | summary |