ValPro 2 Plus, VaPro 2 Plus Pocket
FDA 510(k) clearance K183253 · decided 2018-12-18
Clearance details
- K-number
- K183253
- Device name
- ValPro 2 Plus, VaPro 2 Plus Pocket
- Applicant
- Hollister Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2018-11-21
- Decision date
- 2018-12-18
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- GBM
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Libertyville, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.