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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 K180893
Device Name IHM Technology Bandage
Applicant
Protege Biomedical
10909 Valley View Rd.
Eden Prairie,  MN  55344
Applicant Contact Mike Corcoran
Correspondent
Protege Biomedical
10909 Valley View Rd.
Eden Prairie,  MN  55344
Correspondent Contact Mike Corcoran
Classification Product Code
QSY  
Date Received04/05/2018
Decision Date 09/19/2018
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
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