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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pack, Heat, Moist
510(k) Number K150139
Device Name Rachel's Remedy
Applicant
Rachel'S Remedies, LLC
542 Parkside Ave.
Buffalo,  NY  14216
Applicant Contact Rachel E. Jackson
Correspondent
Rachel'S Remedies, LLC
542 Parkside Ave.
Buffalo,  NY  14216
Correspondent Contact Rachel E. Jackson
Regulation Number890.5730
Classification Product Code
IMA  
Subsequent Product Code
IMD  
Date Received01/22/2015
Decision Date 05/22/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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