510(k) K800844
- Device
- MEDEBAR XL
- Applicant
- MEDEFIELD PTY. LTD.
- 510(k) number
- K800844
- Product code
- KTA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-05-30
- Date received
- 1980-04-15
- Regulation
- 510(k) Premarket Notification
- Classification name
- Medium, Contrast, Radiologic
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Radiology
- 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 |
| K800459 | BARIUM SULFATE, USP IN SUSPENSION | Central Pharmaceuticals, Inc. | 1980-05-30 |
| 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 |
| K760736 | BARIMEX, BARIUM SULFATE COMPOUND | C.R. Bard, Inc. | 1976-11-09 |
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