JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810
FDA 510(k) clearance K030053 · decided 2003-03-31
Clearance details
- K-number
- K030053
- Device name
- JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810
- Applicant
- Jomed AG
- Decision
- Substantially Equivalent
- Date received
- 2002-12-23
- Decision date
- 2003-03-31
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- 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.