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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Microneedle Device
510(k) Number K222199
Device Name Collagen P.I.N. (Percutaneous Induction Needling)
Applicant
Induction Therapies, LLC
1920 Stanley Gault Pkwy., Suite 100
Louisville,  KY  40223
Applicant Contact Amelia Aslam
Correspondent
Technology Sciences Group, Inc.
1150 18th St. NW, Suite 475
Washington,  DC  20036
Correspondent Contact Laurie A. Clarke
Regulation Number878.4430
Classification Product Code
QAI  
Date Received07/22/2022
Decision Date 10/21/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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