LEAD CONVERSION KIT, MODEL 341
FDA 510(k) clearance K781111 · decided 1978-08-31
Clearance details
- K-number
- K781111
- Device name
- LEAD CONVERSION KIT, MODEL 341
- Applicant
- Edwards Pacemaker Systems
- Decision
- Substantially Equivalent
- Date received
- 1978-07-03
- Decision date
- 1978-08-31
- Days to decision
- 59 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.