The following data is part of a premarket notification filed by Hand Innovations, Llc. with the FDA for Dorsal Nail Plate, Anatomical.
| Device ID | K052248 |
| 510k Number | K052248 |
| Device Name: | DORSAL NAIL PLATE, ANATOMICAL |
| Classification | Plate, Fixation, Bone |
| Applicant | HAND INNOVATIONS, LLC. 8905 SW 87TH AVENUE SUITE 220 Miami, FL 33176 |
| Contact | Ernesto Hernandez |
| Correspondent | Ernesto Hernandez HAND INNOVATIONS, LLC. 8905 SW 87TH AVENUE SUITE 220 Miami, FL 33176 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-18 |
| Decision Date | 2005-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304535268 | K052248 | 000 |
| 00887868072796 | K052248 | 000 |
| 00887868072772 | K052248 | 000 |
| 00887868070747 | K052248 | 000 |
| 00887868070723 | K052248 | 000 |
| 00887868546044 | K052248 | 000 |
| 00887868546020 | K052248 | 000 |