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 |