GELPOINT PATH TRANSANAL ACCESS PLATFORM— 510(k) K133393
Substantially EquivalentApplied Medical Resources Corp.
FDA 510(k) clearance K133393 for GELPOINT PATH TRANSANAL ACCESS PLATFORM, Substantially Equivalent on 2014-01-02. Applicant: Applied Medical Resources Corp.. Device class: 2.
Clearance details
- Applicant
- Applied Medical Resources Corp.
- Product code
- Code FER
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rancho Santa, CA, US
Recent devices under product code FER
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