The following data is part of a premarket notification filed by Hemex Scientific, Inc. with the FDA for Duromedics Cardiac Valve Sizer Set.
| Device ID | K853313 |
| 510k Number | K853313 |
| Device Name: | DUROMEDICS CARDIAC VALVE SIZER SET |
| Classification | Sizer, Heart-valve, Prosthesis |
| Applicant | HEMEX SCIENTIFIC, INC. 1300 A EAST ANDERSON LN. Austin, TX 78752 |
| Contact | John L Ely |
| Correspondent | John L Ely HEMEX SCIENTIFIC, INC. 1300 A EAST ANDERSON LN. Austin, TX 78752 |
| Product Code | DTI |
| CFR Regulation Number | 870.3945 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-07 |
| Decision Date | 1985-11-01 |