MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter— 510(k) K143669
Substantially EquivalentMedgyn Products, Inc.
FDA 510(k) clearance K143669 for MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter, Substantially Equivalent on 2015-11-23. Applicant: Medgyn Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Medgyn Products, Inc.
- Product code
- Code MQF
- Device class
- Class 2
- Regulation
- 21 CFR 884.6110
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Addison, IL, US
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