TI-COMFORTER
FDA 510(k) clearance K780927 · decided 1978-08-09
Clearance details
- K-number
- K780927
- Device name
- TI-COMFORTER
- Applicant
- Alden Products Co.
- Decision
- Substantially Equivalent
- Date received
- 1978-06-05
- Decision date
- 1978-08-09
- Days to decision
- 65 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.