PURESPERM— 510(k) K980814
Substantially EquivalentNidacon International AB
FDA 510(k) clearance K980814 for PURESPERM, Substantially Equivalent on 1998-06-23. Applicant: Nidacon International AB. Device class: 2.
Clearance details
- Applicant
- Nidacon International AB
- Product code
- Code MQL
- Device class
- Class 2
- Regulation
- 21 CFR 884.6180
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Deer Field, IL, US
Recent devices under product code MQL
view allMore clearances from Nidacon International AB
view allData sourced from openFDA. This site is unofficial and independent of the FDA.