The following data is part of a premarket notification filed by Newdeal S.a. with the FDA for Calcamea Plate.
| Device ID | K041786 |
| 510k Number | K041786 |
| Device Name: | CALCAMEA PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | NEWDEAL S.A. 9109 COPENHAVER DR. Potomac, MD 20854 |
| Contact | Norma F Estrin |
| Correspondent | Norma 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 | 2004-07-01 |
| Decision Date | 2004-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780125853 | K041786 | 000 |