The following data is part of a premarket notification filed by Newdeal Sas with the FDA for Newdeal Compression Plates.
| Device ID | K093914 |
| 510k Number | K093914 |
| Device Name: | NEWDEAL COMPRESSION PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | NEWDEAL SAS 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Stephen Beier |
| Correspondent | Stephen Beier NEWDEAL SAS 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-22 |
| Decision Date | 2011-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780044321 | K093914 | 000 |
| 10381780044314 | K093914 | 000 |
| 10381780044307 | K093914 | 000 |
| 00885556849620 | K093914 | 000 |
| 00885556849613 | K093914 | 000 |
| 00885556849606 | K093914 | 000 |