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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 K240454
Device Name RESPONDER® Polysaccharide Hemostat
Applicant
Starch Medical, Inc.
2150 Ringwood Ave.
San Jose,  CA  95131
Applicant Contact Alice Li
Correspondent
Starch Medical, Inc.
2150 Ringwood Ave.
San Jose,  CA  95131
Correspondent Contact Alice Li
Classification Product Code
QSY  
Date Received02/15/2024
Decision Date 03/15/2024
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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