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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dressing, wound, drug
510(k) Number K182725
Device Name Apis
Applicant
SweetBio, Inc
20 Dudley Street, Suite 900
Memphis,  TN  38103 -4904
Applicant Contact Kayla Graff
Correspondent
Kapstone Medical, LLC
PO Box 969
Leicester,  NC  28748
Correspondent Contact Carolyn Guthrie
Classification Product Code
FRO  
Subsequent Product Code
KGN  
Date Received09/28/2018
Decision Date 05/31/2019
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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