The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap Novosyn Absorbable Suture.
| Device ID | K122734 |
| 510k Number | K122734 |
| Device Name: | AESCULAP NOVOSYN ABSORBABLE 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 | 2012-09-06 |
| Decision Date | 2012-12-18 |
| Summary: | summary |