CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12
FDA 510(k) clearance K041890 · decided 2004-09-22
Clearance details
- K-number
- K041890
- Device name
- CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12
- Applicant
- Cryocor, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-07-12
- Decision date
- 2004-09-22
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- OCL
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.