The following data is part of a premarket notification filed by Newdeal S.a. with the FDA for Hallu Plates.
| Device ID | K021626 |
| 510k Number | K021626 |
| Device Name: | HALLU PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | NEWDEAL S.A. 9109 COPENHAVER DR. Potomac, MD 20854 |
| Contact | Norman F Estrin |
| Correspondent | Norman F Estrin NEWDEAL S.A. 9109 COPENHAVER DR. Potomac, MD 20854 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-17 |
| Decision Date | 2002-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780064404 | K021626 | 000 |
| M248117012ND1 | K021626 | 000 |
| M248117010ND1 | K021626 | 000 |
| 10381780043577 | K021626 | 000 |
| 10381780043553 | K021626 | 000 |
| 10381780043539 | K021626 | 000 |
| 10381780043515 | K021626 | 000 |
| 10381780043492 | K021626 | 000 |
| 10381780043478 | K021626 | 000 |
| 10381780043454 | K021626 | 000 |
| 10381780043430 | K021626 | 000 |
| 10381780043416 | K021626 | 000 |
| 10381780043393 | K021626 | 000 |
| 10381780043379 | K021626 | 000 |
| M248117014ND1 | K021626 | 000 |
| 10381780047537 | K021626 | 000 |
| 10381780047551 | K021626 | 000 |
| 10381780047810 | K021626 | 000 |
| 10381780047797 | K021626 | 000 |
| 10381780047773 | K021626 | 000 |
| M248117112ND1 | K021626 | 000 |
| M248117110ND1 | K021626 | 000 |
| 10381780047711 | K021626 | 000 |
| M248117032ND1 | K021626 | 000 |
| M248117030ND1 | K021626 | 000 |
| 10381780047650 | K021626 | 000 |
| 10381780047636 | K021626 | 000 |
| 10381780047612 | K021626 | 000 |
| M248117022ND1 | K021626 | 000 |
| M248117020ND1 | K021626 | 000 |
| 10381780043355 | K021626 | 000 |