The following data is part of a premarket notification filed by Mesynthes Ltd with the FDA for Endoform Dermal Template.
| Device ID | K092096 |
| 510k Number | K092096 |
| Device Name: | ENDOFORM DERMAL TEMPLATE |
| Classification | Dressing, Wound, Collagen |
| Applicant | MESYNTHES LTD 49 PLAIN STREET North Attleboro, MA 02760 -4153 |
| Contact | Mary Mcnamara |
| Correspondent | Mary Mcnamara MESYNTHES LTD 49 PLAIN STREET North Attleboro, MA 02760 -4153 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-14 |
| Decision Date | 2010-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09421904065642 | K092096 | 000 |
| 09421906017359 | K092096 | 000 |
| 09421906017366 | K092096 | 000 |
| 09421906017373 | K092096 | 000 |
| 09421906017380 | K092096 | 000 |
| 09421906017397 | K092096 | 000 |
| 09421906017298 | K092096 | 000 |
| 09421906017410 | K092096 | 000 |
| 09421904065628 | K092096 | 000 |
| 09421904065659 | K092096 | 000 |
| 09421905067355 | K092096 | 000 |
| 09421905067362 | K092096 | 000 |
| 09421905067331 | K092096 | 000 |
| 09421905067324 | K092096 | 000 |
| 09421904065635 | K092096 | 000 |
| 09421906017342 | K092096 | 000 |