MEDEBAR M
FDA 510(k) clearance K800841 · decided 1980-05-30
Clearance details
- K-number
- K800841
- Device name
- MEDEBAR M
- Applicant
- Medefield Pty. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1980-04-15
- Decision date
- 1980-05-30
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- KTA
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MEDEFIZZ A & MEDEFIZZ B (K800843) | Medefield Pty. , Ltd. | 1980-06-17 |
| MEDEFOAM-2 (K800840) | Medefield Pty. , Ltd. | 1980-06-17 |
| BARIUM SULFATE, USP IN SUSPENSION (K800459) | Central Pharmaceuticals, Inc. | 1980-05-30 |
| MEDEBAR XAC-90 (K800842) | Medefield Pty. , Ltd. | 1980-05-30 |
| MEDESCAN (K800839) | Medefield Pty. , Ltd. | 1980-05-30 |
| MEDEBAR XL (K800844) | Medefield Pty. , Ltd. | 1980-05-30 |
| BARIMEX, BARIUM SULFATE COMPOUND (K760736) | C.R. Bard, Inc. | 1976-11-09 |
Recalls involving this device
No recalls on record reference this clearance.