FAS SET #4551— 510(k) K013497
Substantially EquivalentGynetics Medical Products NV
FDA 510(k) clearance K013497 for FAS SET #4551, Substantially Equivalent on 2001-11-09. Applicant: Gynetics Medical Products NV. Device class: 2.
Clearance details
- Applicant
- Gynetics Medical Products NV
- Product code
- Code MQE
- Device class
- Class 2
- Regulation
- 21 CFR 884.6100
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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