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510(k) K242066

iSage Rx by Amalgam Rx, Inc. — Product Code NDC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2024
Date Received
July 15, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Drug Dose
Device Class
Class II
Regulation Number
868.1890
Review Panel
CH
Submission Type

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