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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 K220646
Device Name Play&Joy InvisiLube Lubricant Capsule
Applicant
Innovemed Bio-Tech Co., Ltd.
6f, # 184, Sec. 2, Chongqing N. Rd., Datong Dist.,
Taipei City,  TW 103
Applicant Contact David Chien
Correspondent
Charles Shen
37 Winding Ridge
Oakland,  NJ  07436
Correspondent Contact Charles Shen
Regulation Number884.5300
Classification Product Code
NUC  
Date Received03/04/2022
Decision Date 07/10/2023
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
Predetermined Change
Control Plan Authorized		 No
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