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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Comb, Hair
510(k) Number K181878
Device Name Kiierr 272 Laser, Kiierr 148 Laser
Applicant
Kiierr International, LLC
863 East Downington Avenue
Salt Lake City,  UT  84105 -3211
Applicant Contact Michael Anderson
Correspondent
NST Consultants, Inc
641 Shunpike Road, Suite 311
Chatham,  NJ  07928
Correspondent Contact Raymond R. Blanche
Regulation Number890.5500
Classification Product Code
OAP  
Date Received07/13/2018
Decision Date 09/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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