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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blanket, Neonatal Phototherapy
510(k) Number K142416
Device Name Luma Wrap
Applicant
Salter Labs
2365 Camino Vida Roble
Carlsbad,  CA  92011
Applicant Contact Aurelia Browndridge
Correspondent
Salter Labs
2365 Camino Vida Roble
Carlsbad,  CA  92011
Correspondent Contact Aurelia Brownridge
Regulation Number880.5700
Classification Product Code
PDH  
Date Received08/28/2014
Decision Date 06/12/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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