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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 K192012
Device Name Capillus 112, Capillus 244
Applicant
Capillus
1715 NW 82nd Ave.
Doral,  FL  33126
Applicant Contact Patricia Schnoor
Correspondent
Capillus
1715 NW 82nd Ave.
Doral,  FL  33126
Correspondent Contact Patricia Schnoor
Regulation Number890.5500
Classification Product Code
OAP  
Date Received07/29/2019
Decision Date 09/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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