The following data is part of a premarket notification filed by Dornier Medtech America, Inc. with the FDA for Urotract I.
| Device ID | K955019 |
| 510k Number | K955019 |
| Device Name: | UROTRACT I |
| Classification | Table, Cystometric, Non-electric And Accessories |
| Applicant | DORNIER MEDTECH AMERICA, INC. 1155 ROBERTS BLVD. Kennesaw, GA 30144 |
| Contact | Deborah Moore |
| Correspondent | Deborah Moore DORNIER MEDTECH AMERICA, INC. 1155 ROBERTS BLVD. Kennesaw, GA 30144 |
| Product Code | KQS |
| CFR Regulation Number | 876.4890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-02 |
| Decision Date | 1995-12-06 |