The following data is part of a premarket notification filed by Newdeal S.a. with the FDA for Newdeal K Wire.
| Device ID | K022599 |
| 510k Number | K022599 |
| Device Name: | NEWDEAL K WIRE |
| Classification | Pin, Fixation, Smooth |
| 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 | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-05 |
| Decision Date | 2002-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780064480 | K022599 | 000 |
| 10381780064473 | K022599 | 000 |
| 10381780064466 | K022599 | 000 |
| 10381780064374 | K022599 | 000 |
| 10381780064367 | K022599 | 000 |
| 10381780064459 | K022599 | 000 |
| 10381780064442 | K022599 | 000 |
| 10381780045861 | K022599 | 000 |