The following data is part of a premarket notification filed by Newdeal S.a. with the FDA for B-bop Plate.
| Device ID | K052152 |
| 510k Number | K052152 |
| Device Name: | B-BOP PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | NEWDEAL S.A. 311 ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Contact | Judith E O'grady |
| Correspondent | Judith E O'grady NEWDEAL S.A. 311 ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-08 |
| Decision Date | 2005-09-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780047865 | K052152 | 000 |
| 10381780043669 | K052152 | 000 |
| 10381780043676 | K052152 | 000 |
| 10381780043683 | K052152 | 000 |
| 10381780047520 | K052152 | 000 |
| 10381780047544 | K052152 | 000 |
| 10381780047568 | K052152 | 000 |
| 10381780047582 | K052152 | 000 |
| 10381780047605 | K052152 | 000 |
| 10381780047629 | K052152 | 000 |
| 10381780047643 | K052152 | 000 |
| 10381780047780 | K052152 | 000 |
| 10381780047803 | K052152 | 000 |
| 10381780047827 | K052152 | 000 |
| 10381780047834 | K052152 | 000 |
| 10381780047841 | K052152 | 000 |
| 10381780047858 | K052152 | 000 |
| 10381780043652 | K052152 | 000 |