IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD.
FDA 510(k) clearance K800603 · decided 1980-03-25
Clearance details
- K-number
- K800603
- Device name
- IMPLANTABLE PROGRAMMABLE UNIPOLAR CARD.
- Applicant
- Telectronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-03-17
- Decision date
- 1980-03-25
- Days to decision
- 8 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TELECTRONICS PASAR MODEL 4171 PG (P850027/S006) | Telectronics, Inc. | 1990-05-09 |
| TELECTRONICS PASAR MODEL 4171 PG (P850027/S003) | Telectronics, Inc. | 1990-03-22 |
| TELECTRONICS PASAR MODEL 4171 PG (P850027/S005) | Telectronics, Inc. | 1990-02-02 |
| TELECTRONICS PASAR MODEL 4171 PG (P850027/S002) | Telectronics, Inc. | 1989-04-18 |
| TELECTRONICS PASAR MODEL 4171 PG (P850027/S001) | Telectronics, Inc. | 1987-03-27 |
| TELECTRONICS PASAR MODEL 4171 PG (P850027) | Telectronics, Inc. | 1986-09-30 |