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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene
510(k) Number K210675
Device Name EasyWhip
Applicant
Winter Innovations, Inc.
2450 Ej Chapman Dr., Suite 114
Knoxville,  TN  37996
Applicant Contact Lia Winter
Correspondent
Winter Innovations, Inc.
2450 Ej Chapman Dr., Suite 114
Knoxville,  TN  37996
Correspondent Contact Lia Winter
Regulation Number878.5000
Classification Product Code
GAT  
Date Received03/05/2021
Decision Date 05/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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