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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Radiographic, Implantable
510(k) Number K180621
Device Name EchoMark, EchoMark LP
Applicant
Sonavex, Inc.
2835 O'Donnell St.
Suite 200
Baltimore,  MD  21224
Applicant Contact David Narrow
Correspondent
Sonavex, Inc.
2835 O'Donnell St.
Suite 200
Baltimore,  MD  21224
Correspondent Contact David Narrow
Regulation Number878.4300
Classification Product Code
NEU  
Date Received03/09/2018
Decision Date 06/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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