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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 K180923
Device Name Personal Lubricating Jelly
Applicant
Perrigo New York, Inc.
1700 Bathgate Ave.
Bronx,  NY  10457 -7512
Applicant Contact Karen Dombrowski
Correspondent
Phil Triolo and Associates LC
86 Skycrest Land
Salt Lake City,  UT  84108
Correspondent Contact Phil Triolo
Regulation Number884.5300
Classification Product Code
NUC  
Date Received04/09/2018
Decision Date 07/09/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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