Sulopenem SPM 2 µg— 510(k) K251879
Substantially EquivalentLiofilchem
FDA 510(k) clearance K251879 for Sulopenem SPM 2 µg, Substantially Equivalent on 2025-08-12. Applicant: Liofilchem. Device class: 2.
Clearance details
- Applicant
- Liofilchem
- Product code
- Code JTN
- Device class
- Class 2
- Regulation
- 21 CFR 866.1620
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
Recent devices under product code JTN
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