510(k) K852127
- Device
- AMSCO URO-ENDO MOBILE TABLE
- Applicant
- AMERICAN STERILIZER CO.
- 510(k) number
- K852127
- Product code
- KQS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-08-08
- Date received
- 1985-05-15
- Regulation
- 876.4890
- Classification name
- Table, Cystometric, Non-electric And Accessories
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES A SPALLINA
- Address
- 2424 W. 23rd St. P.O. Box 620 Erie PA US 16514 16514
FDA Registration Numbers#
- 9612030
- 9610903
- 2243057
- 1418964
- 9611388
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KQS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K955019 | UROTRACT I | Dornier Medtech America, Inc. | 1995-12-06 |
| 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 |
| 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#
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FDA Review#
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