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510(k) K251879

Sulopenem SPM 2 µg by Liofilchem — Product Code JTN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2025
Date Received
June 18, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Discs, Antimicrobial
Device Class
Class II
Regulation Number
866.1620
Review Panel
MI
Submission Type

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