The following data is part of a premarket notification filed by Atrium Medical Corporation with the FDA for Prolite Mesh, Prolite Ultra Mesh, Proloop Mesh Plug.
| Device ID | K151437 |
| 510k Number | K151437 |
| Device Name: | ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | ATRIUM MEDICAL CORPORATION 5 WENTWORTH DRIVE Hudson, NH 03051 |
| Contact | Timothy J. Talcott |
| Correspondent | Timothy J. Talcott ATRIUM MEDICAL CORPORATION 5 WENTWORTH DRIVE Hudson, NH 03051 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-29 |
| Decision Date | 2015-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20650862300011 | K151437 | 000 |
| 20650862300240 | K151437 | 000 |
| 20650862300257 | K151437 | 000 |
| 20650862301018 | K151437 | 000 |
| 20650862301025 | K151437 | 000 |
| 20650862301032 | K151437 | 000 |
| 20650862301063 | K151437 | 000 |
| 20650862301117 | K151437 | 000 |
| 20650862301124 | K151437 | 000 |
| 20650862300233 | K151437 | 000 |
| 20650862300202 | K151437 | 000 |
| 20650862300127 | K151437 | 000 |
| 20650862300028 | K151437 | 000 |
| 20650862300035 | K151437 | 000 |
| 20650862300042 | K151437 | 000 |
| 20650862300059 | K151437 | 000 |
| 20650862300066 | K151437 | 000 |
| 20650862300073 | K151437 | 000 |
| 20650862300097 | K151437 | 000 |
| 20650862300103 | K151437 | 000 |
| 20650862301599 | K151437 | 000 |
| 20650862301605 | K151437 | 000 |
| 20650862302015 | K151437 | 000 |
| 20650862309038 | K151437 | 000 |
| 20650862309083 | K151437 | 000 |
| 20650862309090 | K151437 | 000 |
| 20650862309106 | K151437 | 000 |
| 20650862309113 | K151437 | 000 |
| 20650862309205 | K151437 | 000 |
| 20650862309212 | K151437 | 000 |
| 20650862309229 | K151437 | 000 |
| 20650862309021 | K151437 | 000 |
| 20650862309014 | K151437 | 000 |
| 20650862309007 | K151437 | 000 |
| 20650862302046 | K151437 | 000 |
| 20650862302053 | K151437 | 000 |
| 20650862302060 | K151437 | 000 |
| 20650862302077 | K151437 | 000 |
| 20650862302084 | K151437 | 000 |
| 20650862302107 | K151437 | 000 |
| 20650862302114 | K151437 | 000 |
| 20650862305092 | K151437 | 000 |
| 20650862309236 | K151437 | 000 |