The following data is part of a premarket notification filed by Justright Surgical, Llc with the FDA for Justright 5mm Stapler, Justright 5mm Reload.
| Device ID | K132472 |
| 510k Number | K132472 |
| Device Name: | JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD |
| Classification | Staple, Implantable |
| Applicant | JUSTRIGHT SURGICAL, LLC 128 Blye HIll Landing Newbury, NH 03255 |
| Contact | Michele Lucey |
| Correspondent | Michele Lucey JUSTRIGHT SURGICAL, LLC 128 Blye HIll Landing Newbury, NH 03255 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-07 |
| Decision Date | 2014-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10865163000116 | K132472 | 000 |
| 10865163000109 | K132472 | 000 |