TULANE HEAT-PACK
FDA 510(k) clearance K790480 · decided 1979-04-03
Clearance details
- K-number
- K790480
- Device name
- TULANE HEAT-PACK
- Applicant
- Tulane
- Decision
- Substantially Equivalent
- Date received
- 1979-03-08
- Decision date
- 1979-04-03
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- IMD
- Device class
- 1
- Regulation number
- 890.5710
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.