The following data is part of a premarket notification filed by Medivators, Inc. with the FDA for Dsd-91(tm) Disinfector For Flexible Endoscopes.
| Device ID | K914145 |
| 510k Number | K914145 |
| Device Name: | DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES |
| Classification | Accessories, Cleaning, For Endoscope |
| Applicant | MEDIVATORS, INC. C/O C. G. BUNDY ASSOCIATES 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Contact | Constance G Bundy |
| Correspondent | Constance G Bundy MEDIVATORS, INC. C/O C. G. BUNDY ASSOCIATES 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Product Code | FEB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-16 |
| Decision Date | 1994-02-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04961333242887 | K914145 | 000 |
| 04961333242870 | K914145 | 000 |
| 04961333242863 | K914145 | 000 |
| 00677964035647 | K914145 | 000 |
| 00677964033858 | K914145 | 000 |