The following data is part of a premarket notification filed by Minilap Technologies with the FDA for Mins Needlescopic Resposable Device System.
| Device ID | K132232 |
| 510k Number | K132232 |
| Device Name: | MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | MINILAP TECHNOLOGIES 145 PALISADE STREET Dobbs Ferry, NY 10522 |
| Contact | Allan Alward |
| Correspondent | Allan Alward MINILAP TECHNOLOGIES 145 PALISADE STREET Dobbs Ferry, NY 10522 |
| Product Code | OCW |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-18 |
| Decision Date | 2013-12-04 |
| Summary: | summary |