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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostatic Wound Dressing Without Thrombin Or Other Biologics
510(k) Number K161013
Device Name InnoSEAL Hemostatic Pad
Applicant
Innotherapy, Inc.
Ace Hightechcity2,25, Seonyu-Ro 13-Gil
Yeongdeungpo-Gu
Seoul,  KR 07282
Applicant Contact Moon Sue Lee
Correspondent
Schiff & Company, Inc.
1120 Bloomfield Ave.
West Caldwell,  NJ  07282
Correspondent Contact Robert Schiff
Classification Product Code
QSY  
Date Received04/11/2016
Decision Date 11/29/2016
Decision Substantially Equivalent (SESE)
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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