HEATER PROBE-ACCESS FOR MEDPACIFIC LD5000 LASER -
FDA 510(k) clearance K854500 · decided 1986-02-26
Clearance details
- K-number
- K854500
- Device name
- HEATER PROBE-ACCESS FOR MEDPACIFIC LD5000 LASER -
- Applicant
- Medpacific Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-11-12
- Decision date
- 1986-02-26
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- DPW
- Device class
- 2
- Regulation number
- 870.2100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.