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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 K082047
Device Name SECURACATH CATHETER, MODEL SPK01
Applicant
Interrad Medical, Inc.
18555 37th Ave. N.
Plymouth,  MN  55446
Applicant Contact Sew-Wah Tay
Correspondent
Interrad Medical, Inc.
18555 37th Ave. N.
Plymouth,  MN  55446
Correspondent Contact Sew-Wah Tay
Regulation Number880.5970
Classification Product Code
OKC  
Date Received07/18/2008
Decision Date 09/30/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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