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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Personal
510(k) Number K250142
Device Name Water-based Lubricant
Applicant
Global Protection Corp.
12 Channel St.
Boston,  MA  02210
Applicant Contact Christina Cataldo
Correspondent
Global Protection Corp.
12 Channel St.
Boston,  MA  02210
Correspondent Contact Christina Cataldo
Regulation Number884.5300
Classification Product Code
NUC  
Date Received01/17/2025
Decision Date 08/08/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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