The following data is part of a premarket notification filed by Dantec Electronics, Inc. with the FDA for Urodyn 1000.
| Device ID | K853119 |
| 510k Number | K853119 |
| Device Name: | URODYN 1000 |
| Classification | Retractor, Self-retaining |
| Applicant | DANTEC ELECTRONICS, INC. 6 PEARL COURT Allendale, NJ 07401 |
| Contact | Ole Strange |
| Correspondent | Ole Strange DANTEC ELECTRONICS, INC. 6 PEARL COURT Allendale, NJ 07401 |
| Product Code | FFO |
| CFR Regulation Number | 876.4730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-25 |
| Decision Date | 1985-10-04 |