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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cord, Retraction
510(k) Number K162948
Device Name Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials
Applicant
Kerr Corporation
1717 W. Collins Ave.
Orange,  CA  92867
Applicant Contact Jennifer Dzidrums
Correspondent
Sybron Dental Specialties
1717 W. Collins Ave.
Orange,  CA  92867
Correspondent Contact Mohammad Saad Ansari
Classification Product Code
MVL  
Date Received10/21/2016
Decision Date 08/08/2017
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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