BIOFLOW(TM)
FDA premarket approval P800064 · decided 1982-03-10
Approval details
- PMA number
- P800064
- Trade name
- BIOFLOW(TM)
- Generic name
- Graft, vascular, hemodialysis access, synthetic/biological composite
- Applicant
- Genetic Laboratories, Inc.
- Date received
- 1980-12-01
- Decision date
- 1982-03-10
- Days to decision
- 464 days
- Decision code
- APPR
- Product code
- MCI
- Advisory committee
- Obstetrics/Gynecology
- Expedited review
- No
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PERI-GUARD PERICARDIAL PATCH (K842066) | Genetic Laboratories, Inc. | 1985-12-30 |
| SUTURE STRIP (K842621) | Genetic Laboratories, Inc. | 1984-10-25 |
| PERIGUARD PERICARDIAL PATCH (K821532) | Genetic Laboratories, Inc. | 1982-08-19 |