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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Surgical, Absorbable, Polydioxanone
510(k) Number K172602
Device Name Miracu
Applicant
Feeltech Co., Ltd.
3, 4 Floor, Standard Factory, 2-Dong, 15 Jayumuyeok 2-Gil
Gunsan-Si,  KR 573-540
Applicant Contact Keun-Sik Kim
Correspondent
Albert Rego, PhD, Inc.
27001 La Paz Rd., #314
Mission Viejo,  CA  92691
Correspondent Contact Albert Rego
Regulation Number878.4840
Classification Product Code
NEW  
Date Received08/30/2017
Decision Date 11/14/2018
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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