AMSELF CLOSED CATHETERIZATION SYSTEM— 510(k) K082831
Substantially EquivalentAmsino International, Inc.
FDA 510(k) clearance K082831 for AMSELF CLOSED CATHETERIZATION SYSTEM, Substantially Equivalent on 2008-10-23. Applicant: Amsino International, Inc.. Device class: 2.
Clearance details
- Applicant
- Amsino International, Inc.
- Product code
- Code FCM
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Pomona, CA, US
Recent devices under product code FCM
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Data sourced from openFDA. This site is unofficial and independent of the FDA.