The following data is part of a premarket notification filed by Ehicon Inc. with the FDA for Ultrapro Advanced Macroporous Partically Absorbable Mesh.
| Device ID | K150906 |
| 510k Number | K150906 |
| Device Name: | ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | EHICON INC. ROUTE22 WEST, P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Contact | Susan Lin |
| Correspondent | Susan Lin ELTHICON INC. ROUTE22 WEST, P.O. BOX 151 Somerville, NJ 08876 -0151 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-03 |
| Decision Date | 2015-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705031237032 | K150906 | 000 |
| 20705031237022 | K150906 | 000 |
| 20705031237015 | K150906 | 000 |
| 20705031237008 | K150906 | 000 |
| 20705031236995 | K150906 | 000 |
| 10705031236981 | K150906 | 000 |
| 10705031236974 | K150906 | 000 |
| 10705031236967 | K150906 | 000 |
| 10705031236950 | K150906 | 000 |