The following data is part of a premarket notification filed by Newdeal S.a. with the FDA for Large Uni-clip Staple.
| Device ID | K061594 |
| 510k Number | K061594 |
| Device Name: | LARGE UNI-CLIP STAPLE |
| Classification | Staple, 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 | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-08 |
| Decision Date | 2006-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780064435 | K061594 | 000 |
| M248314827SND1 | K061594 | 000 |
| 10381780052807 | K061594 | 000 |
| 10381780052791 | K061594 | 000 |
| 10381780052784 | K061594 | 000 |