The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Lyoplant Onlay.
| Device ID | K122791 |
| 510k Number | K122791 |
| Device Name: | LYOPLANT ONLAY |
| Classification | Dura Substitute |
| Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Denise Adams |
| Correspondent | Denise Adams AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | GXQ |
| CFR Regulation Number | 882.5910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-12 |
| Decision Date | 2013-06-04 |
| Summary: | summary |