CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE
FDA 510(k) clearance K132896 · decided 2013-12-02
Clearance details
- K-number
- K132896
- Device name
- CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE
- Applicant
- Asia-Med GmbH and CO KG
- Decision
- Substantially Equivalent
- Date received
- 2013-09-16
- Decision date
- 2013-12-02
- Days to decision
- 77 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.