ULTRASTIM KIT— 510(k) K013532
Substantially EquivalentAxelgaard Mfg. Co., Ltd.
FDA 510(k) clearance K013532 for ULTRASTIM KIT, Substantially Equivalent on 2002-08-22. Applicant: Axelgaard Mfg. Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Axelgaard Mfg. Co., Ltd.
- Product code
- Code GZJ
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fallbrook, CA, US
Recent devices under product code GZJ
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Data sourced from openFDA. This site is unofficial and independent of the FDA.