The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Ventrofil Tension Relief Suture Set.
| Device ID | K904435 |
| 510k Number | K904435 |
| Device Name: | VENTROFIL TENSION RELIEF SUTURE SET |
| Classification | Retention Device, Suture |
| Applicant | AESCULAP, INC. 875 STANTON RD. Burlingame, CA 94010 |
| Contact | Robin Bush |
| Correspondent | Robin Bush AESCULAP, INC. 875 STANTON RD. Burlingame, CA 94010 |
| Product Code | KGS |
| CFR Regulation Number | 878.4930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-28 |
| Decision Date | 1991-08-29 |