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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 K210751
Device Name S.E.A.L. Hemostatic Wound Spray
Applicant
Bc3 Technologies, Inc.
3701-A Southwestern Blvd.
Baltimore,  MD  21229
Applicant Contact Wayne L. Grube
Correspondent
Bc3 Technologies, Inc.
3701-A Southwestern Blvd.
Baltimore,  MD  21229
Correspondent Contact Wayne L. Grube
Classification Product Code
QSY  
Date Received03/12/2021
Decision Date 02/02/2023
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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