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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name orthosis, cranial
510(k) Number K193383
Device Name SnugKap
HeadStart, Ltd.
1550 E. Higgins Road, Suite 123
Elk Grove Village,  IL  60007
Applicant Contact James McCartney
1050 K Street NW, Suite 1000
Washington,  DC  20001
Correspondent Contact Dave McGurl
Regulation Number882.5970
Classification Product Code
Date Received12/05/2019
Decision Date 06/07/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No