PURESPERM 40 AND PURESPERM 80— 510(k) K002623
Substantially EquivalentNidacon International AB
FDA 510(k) clearance K002623 for PURESPERM 40 AND PURESPERM 80, Substantially Equivalent on 2000-11-20. 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
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