H-H TENDEON IMPLANT
FDA 510(k) clearance K843013 · decided 1985-04-17
Clearance details
- K-number
- K843013
- Device name
- H-H TENDEON IMPLANT
- Applicant
- Holter-Hausner Intl.
- Decision
- Substantially Equivalent
- Date received
- 1984-07-31
- Decision date
- 1985-04-17
- Days to decision
- 260 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.