The following data is part of a premarket notification filed by Newdeal Sas with the FDA for Modified: Newdeal Hallu Plates.
| Device ID | K093781 |
| 510k Number | K093781 |
| Device Name: | MODIFIED: NEWDEAL HALLU 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-09 |
| Decision Date | 2010-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780047766 | K093781 | 000 |
| 10381780043522 | K093781 | 000 |
| 10381780043508 | K093781 | 000 |
| 10381780043485 | K093781 | 000 |
| 10381780043461 | K093781 | 000 |
| 10381780043447 | K093781 | 000 |
| 10381780043423 | K093781 | 000 |
| 10381780043409 | K093781 | 000 |
| 10381780043386 | K093781 | 000 |
| 10381780043546 | K093781 | 000 |
| 10381780043560 | K093781 | 000 |
| 10381780047742 | K093781 | 000 |
| 10381780047728 | K093781 | 000 |
| 10381780047704 | K093781 | 000 |
| 10381780047681 | K093781 | 000 |
| 10381780047667 | K093781 | 000 |
| 10381780047506 | K093781 | 000 |
| 10381780047483 | K093781 | 000 |
| 10381780043584 | K093781 | 000 |
| 10381780043362 | K093781 | 000 |