SEVEN STAR NEEDLE
FDA 510(k) clearance K052723 · decided 2006-01-13
Clearance details
- K-number
- K052723
- Device name
- SEVEN STAR NEEDLE
- Applicant
- Helio Medical Supplies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-29
- Decision date
- 2006-01-13
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- MQX
- Device class
- 2
- Regulation number
- 880.5580
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.