The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap Monomax Absorbable Suture.
| Device ID | K100876 |
| 510k Number | K100876 |
| Device Name: | AESCULAP MONOMAX ABSORBABLE SUTURE |
| Classification | Suture, Recombinant Technology |
| Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Kathy A Racosky |
| Correspondent | Kathy A Racosky AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | NWJ |
| CFR Regulation Number | 878.4494 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-30 |
| Decision Date | 2010-07-14 |
| Summary: | summary |