The following data is part of a premarket notification filed by Neosurgical Ltd with the FDA for Neoclose 2 Autoanchor Pack Us, Neoclose 4 Autoanchor Pack Us.
| Device ID | K142903 |
| 510k Number | K142903 |
| Device Name: | NeoClose 2 AutoAnchor Pack US, NeoClose 4 AutoAnchor Pack US |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | NEOSURGICAL LTD BLOCK 12 GALWAY TECHNOLOGY PARK, PARKMORE Galway, IE Ei |
| Contact | Oria Brennan |
| Correspondent | Oria 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 | 2014-10-06 |
| Decision Date | 2014-11-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391529640569 | K142903 | 000 |
| 05391529640231 | K142903 | 000 |
| 05391529640200 | K142903 | 000 |
| 05391529640170 | K142903 | 000 |
| 05391529640132 | K142903 | 000 |
| 05391529640118 | K142903 | 000 |
| 05391529640095 | K142903 | 000 |
| 05391529640071 | K142903 | 000 |
| 05391529640026 | K142903 | 000 |