The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Monosyn Quick Synthetic Absorbable Surgical Suture.
| Device ID | K171001 |
| 510k Number | K171001 |
| Device Name: | Monosyn Quick Synthetic Absorbable Surgical Suture |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| 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 | GAM |
| CFR Regulation Number | 878.4493 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-04 |
| Decision Date | 2017-10-23 |
| Summary: | summary |