510(k) K955019
- Device
- UROTRACT I
- Applicant
- DORNIER MEDTECH AMERICA, INC.
- 510(k) number
- K955019
- Product code
- KQS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-12-06
- Date received
- 1995-11-02
- Regulation
- 876.4890
- Classification name
- Table, Cystometric, Non-electric And Accessories
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DEBORAH MOORE
- Address
- 1155 Roberts Blvd. Kennesaw GA US 30144 30144
FDA Registration Numbers#
- 9612030
- 9610903
- 2243057
- 1418964
- 9611388
Source Documents#
Other 510(k) Records For Product Code KQS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K872022 | UROVIEW | Oec-Diasonics, Inc. | 1987-07-16 |
| K864846 | RADIOGRAPHIC - LEG SECTION | American Sterilizer Co. | 1986-12-24 |
| K860040 | HYDRAJUST III UROLOGICAL TABLE | Mallinckrodt Group, Inc. | 1986-02-10 |
| K852127 | AMSCO URO-ENDO MOBILE TABLE | American Sterilizer Co. | 1985-08-08 |
| K801723 | UR 150-UR 150T | Siemens Corp. | 1980-08-13 |
| K791699 | HYDRADJUST II UROLOGICAL TABLE | Sybron Corp. | 1979-10-22 |
| K760522 | TABLE, UROSURGICAL | Mallinckrodt Group, Inc. | 1976-12-16 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases