The following data is part of a premarket notification filed by Kensey Nash Corp. with the FDA for Kensey Nash Macropore Shield.
| Device ID | K071695 |
| 510k Number | K071695 |
| Device Name: | KENSEY NASH MACROPORE SHIELD |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | KENSEY NASH CORP. 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
| Contact | Cindy Varughese |
| Correspondent | Cindy Varughese KENSEY NASH CORP. 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-20 |
| Decision Date | 2007-12-31 |
| Summary: | summary |