JETPREP FLUSHING DEVICE OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-169038
FDA 510(k) clearance K111274 · decided 2012-04-04
Clearance details
- K-number
- K111274
- Device name
- JETPREP FLUSHING DEVICE OL-103037 / OL-133037 / OL-168037 / PE-105038 / PE-150038 / PE-170038 / FU-169038
- Applicant
- Jetprep, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-05-05
- Decision date
- 2012-04-04
- Days to decision
- 335 days
- Clearance type
- Traditional
- Product code
- OCX
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.