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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implanted Subcutaneous Securement Catheter
510(k) Number K210629
Device Name SecurAcath
Applicant
Interrad Medical, Inc.
181 Cheshire Lane, Suite 100
Plymouth,  MN  55441
Applicant Contact Denise Lenz
Correspondent
Libramedical, Inc.
8401 73rd Ave. N.
Suite 63
Minneapolis,  MN  55428
Correspondent Contact Denise Lenz
Regulation Number880.5970
Classification Product Code
OKC  
Subsequent Product Code
KMK  
Date Received03/02/2021
Decision Date 04/12/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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