The following data is part of a premarket notification filed by Distriflor S.a. with the FDA for Aseptylum, Uni-carrier.
| Device ID | K961714 |
| 510k Number | K961714 |
| Device Name: | ASEPTYLUM, UNI-CARRIER |
| Classification | Burnisher, Operative |
| Applicant | DISTRIFLOR S.A. 10200 SOUTH 45 EAST SANDY Sandy, UT 84070 |
| Contact | Glen Putnam |
| Correspondent | Glen Putnam DISTRIFLOR S.A. 10200 SOUTH 45 EAST SANDY Sandy, UT 84070 |
| Product Code | EKJ |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-02 |
| Decision Date | 1996-06-10 |