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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Insulin
510(k) Number K240158
Device Name Modular Medical MODD1 Insulin Delivery System
Applicant
Modular Medical, Inc.
10740 Thornmint Road
San Diego,  CA  92127
Applicant Contact Kelsie DiPerna
Correspondent
Modular Medical, Inc.
10740 Thornmint Road
San Diego,  CA  92127
Correspondent Contact Kelsie DiPerna
Regulation Number880.5725
Classification Product Code
LZG  
Subsequent Product Codes
FMH   FMI   FPA   KZH  
Date Received01/19/2024
Decision Date 09/04/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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