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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 K901564
Device Name SOLUSPONGE - S-99
Applicant
Sie Medical Supply Co., Inc.
Suite 2222
Two World Trade Center
New York,  NY  10048
Applicant Contact LI YOUSHAN
Correspondent
Sie Medical Supply Co., Inc.
Suite 2222
Two World Trade Center
New York,  NY  10048
Correspondent Contact LI YOUSHAN
Classification Product Code
QSY  
Subsequent Product Code
LYA  
Date Received04/03/1990
Decision Date 02/27/1991
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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