RDI CARDIAC INSULATION PAD
FDA 510(k) clearance K960312 · decided 1996-04-19
Clearance details
- K-number
- K960312
- Device name
- RDI CARDIAC INSULATION PAD
- Applicant
- R D Intl.
- Decision
- Substantially Equivalent
- Date received
- 1996-01-22
- Decision date
- 1996-04-19
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- DWP
- Device class
- 2
- Regulation number
- 870.4475
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Richardson, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.