510(k) K800459
- Device
- Barium Sulfate, Usp In Suspension
- Applicant
- CENTRAL PHARMACEUTICALS, INC.
- 510(k) number
- K800459
- Product code
- KTA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-05-30
- Date received
- 1980-02-29
- Classification name
- Medium, Contrast, Radiologic
- Medical specialty
- Unknown
- Review panel
- Unknown
- Device class
- U
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KTA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K800840 | MEDEFOAM-2 | Medefield Pty. , Ltd. | 1980-06-17 |
| K800843 | MEDEFIZZ A & MEDEFIZZ B | Medefield Pty. , Ltd. | 1980-06-17 |
| K800839 | MEDESCAN | Medefield Pty. , Ltd. | 1980-05-30 |
| K800841 | MEDEBAR M | Medefield Pty. , Ltd. | 1980-05-30 |
| K800842 | MEDEBAR XAC-90 | Medefield Pty. , Ltd. | 1980-05-30 |
| K800844 | MEDEBAR XL | Medefield Pty. , Ltd. | 1980-05-30 |
| K760736 | BARIMEX, BARIUM SULFATE COMPOUND | C.R. Bard, Inc. | 1976-11-09 |