The following data is part of a premarket notification filed by Kensey Nash Corp. with the FDA for Kensey Nash P1076 Collagen Dental Membrane, Model 20655-xx.
| Device ID | K091192 |
| 510k Number | K091192 |
| Device Name: | KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX |
| Classification | Barrier, Animal Source, Intraoral |
| Applicant | KENSEY NASH CORP. 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
| Contact | Alyssa Schwartz |
| Correspondent | Alyssa Schwartz KENSEY NASH CORP. 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
| Product Code | NPL |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-23 |
| Decision Date | 2009-11-02 |
| Summary: | summary |