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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K250847
Device Name VaporShield
Applicant
Vault Paragon Group, Inc.
199 E 52nd St. Suite 240
Garden City,  ID  83714
Applicant Contact Sari Luciano
Correspondent
Vault Paragon Group, Inc.
199 E 52nd St. Suite 240
Garden City,  ID  83714
Correspondent Contact Sari Luciano
Regulation Number880.5860
Classification Product Code
MEG  
Subsequent Product Codes
FMF   FMI   ONB  
Date Received03/20/2025
Decision Date 12/12/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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