HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM— 510(k) K011435
Substantially EquivalentHmt, Inc.
FDA 510(k) clearance K011435 for HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM, Substantially Equivalent on 2001-06-22. Applicant: Hmt, Inc.. Device class: 2.
Clearance details
- Applicant
- Hmt, Inc.
- Product code
- Code KPI
- Device class
- Class 2
- Regulation
- 21 CFR 876.5320
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
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Data sourced from openFDA. This site is unofficial and independent of the FDA.