The following data is part of a premarket notification filed by Aroa Biosurgery Limited (formerly Mesynthes Limited) with the FDA for Endoform Reconstructive Template.
| Device ID | K153632 |
| 510k Number | K153632 |
| Device Name: | Endoform Reconstructive Template |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | Aroa Biosurgery Limited (Formerly Mesynthes Limited) 2 Kingsford Smith Place, Airport Oaks Auckland, NZ 2022 |
| Contact | Yasmin Rai |
| Correspondent | Gordon Macfarlane ICON Plc 62 Forest Street Marlborough, MA 01752 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-18 |
| Decision Date | 2016-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09421905067539 | K153632 | 000 |
| 09421904065086 | K153632 | 000 |
| 09421904065079 | K153632 | 000 |
| 09421904065062 | K153632 | 000 |
| 09421904065055 | K153632 | 000 |
| 09421904065048 | K153632 | 000 |
| 09421904065031 | K153632 | 000 |
| 09421904065024 | K153632 | 000 |
| 09421904065017 | K153632 | 000 |
| 09421904065000 | K153632 | 000 |
| 09421906661897 | K153632 | 000 |
| 09421906661880 | K153632 | 000 |
| 09421906661569 | K153632 | 000 |
| 09421906661552 | K153632 | 000 |
| 09421906661927 | K153632 | 000 |
| 09421906661910 | K153632 | 000 |
| 09421904065093 | K153632 | 000 |
| 09421904065109 | K153632 | 000 |
| 09421904065802 | K153632 | 000 |
| 09421904065796 | K153632 | 000 |
| 09421904065789 | K153632 | 000 |
| 09421904065772 | K153632 | 000 |
| 09421904065765 | K153632 | 000 |
| 09421904065208 | K153632 | 000 |
| 09421904065192 | K153632 | 000 |
| 09421904065185 | K153632 | 000 |
| 09421904065178 | K153632 | 000 |
| 09421904065161 | K153632 | 000 |
| 09421904065154 | K153632 | 000 |
| 09421904065147 | K153632 | 000 |
| 09421904065130 | K153632 | 000 |
| 09421904065123 | K153632 | 000 |
| 09421904065116 | K153632 | 000 |
| 09421906661903 | K153632 | 000 |