The following data is part of a premarket notification filed by Neosurgical Ltd with the FDA for Neoclose Hasson, Neoclose Universal.
| Device ID | K131688 |
| 510k Number | K131688 |
| Device Name: | NEOCLOSE HASSON, NEOCLOSE UNIVERSAL |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | NEOSURGICAL LTD BLOCK 12 GALWAY TECHNOLOGY PARK, PARKMORE Galway, IE Ei |
| Contact | Orla Brennan |
| Correspondent | Orla Brennan NEOSURGICAL LTD BLOCK 12 GALWAY TECHNOLOGY PARK, PARKMORE Galway, IE Ei |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-10 |
| Decision Date | 2013-07-18 |
| Summary: | summary |