The following data is part of a premarket notification filed by Newdeal Sas with the FDA for Newdeal Compression Plate.
| Device ID | K070447 |
| 510k Number | K070447 |
| Device Name: | NEWDEAL COMPRESSION PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | NEWDEAL SAS 311 ENTERPRISE DR. Plainsboro, NJ 08536 |
| Contact | Judith E O'grady |
| Correspondent | Judith E O'grady NEWDEAL SAS 311 ENTERPRISE DR. 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 | 2007-02-15 |
| Decision Date | 2007-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780044406 | K070447 | 000 |
| 00885556819791 | K070447 | 000 |
| 00885556819784 | K070447 | 000 |
| 00885556910245 | K070447 | 000 |
| 00885556819906 | K070447 | 000 |
| 00885556819890 | K070447 | 000 |
| 00885556819883 | K070447 | 000 |
| 00885556819869 | K070447 | 000 |
| 00885556819852 | K070447 | 000 |
| 00885556819845 | K070447 | 000 |
| 00885556910320 | K070447 | 000 |
| 00885556910313 | K070447 | 000 |
| 00885556910306 | K070447 | 000 |
| 00885556910290 | K070447 | 000 |
| 00885556819807 | K070447 | 000 |
| 00885556819814 | K070447 | 000 |
| 10381780044390 | K070447 | 000 |
| 10381780044383 | K070447 | 000 |
| 10381780044376 | K070447 | 000 |
| 10381780044369 | K070447 | 000 |
| 10381780044352 | K070447 | 000 |
| M248286340SND1 | K070447 | 000 |
| M248286340ND1 | K070447 | 000 |
| M248286338SND1 | K070447 | 000 |
| M248286338ND1 | K070447 | 000 |
| M248286336SND1 | K070447 | 000 |
| M248286336ND1 | K070447 | 000 |
| 00885556819838 | K070447 | 000 |
| 00885556819821 | K070447 | 000 |
| 00885556910283 | K070447 | 000 |