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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Port & Catheter, Implanted, Subcutaneous, Intravascular
510(k) Number K881256
Device Name NON CORING INFUSION SET
Applicant
Taris Corp.
2386 Shannon Rd.
Fernandina Beach,  FL  32034
Applicant Contact WILLIAM J SCHRODER
Correspondent
Taris Corp.
2386 Shannon Rd.
Fernandina Beach,  FL  32034
Correspondent Contact WILLIAM J SCHRODER
Regulation Number880.5965
Classification Product Code
LJT  
Date Received03/23/1988
Decision Date 04/21/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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