SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE
FDA 510(k) clearance K031716 · decided 2003-07-10
Clearance details
- K-number
- K031716
- Device name
- SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE
- Applicant
- Asia-Med GmbH and CO KG
- Decision
- Substantially Equivalent
- Date received
- 2003-06-03
- Decision date
- 2003-07-10
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- MQX
- Device class
- 2
- Regulation number
- 880.5580
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Littleton, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.