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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 K143335
Device Name Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC)
Applicant
Roosin Medical Devices Co., Ltd.
#8 Yuandong Rd., Kouan Town,
Gaogang
Taizhou,  CN 225321
Applicant Contact Chengyu Shen
Correspondent
Manton Business and Technology Services
853 Dorchester Ln., Unit-B
New Milford,  NJ  07646
Correspondent Contact Charles Shen
Classification Product Code
FRO  
Date Received11/20/2014
Decision Date 06/01/2015
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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