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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 K901419
Device Name DUAL PORT
Applicant
Infusaid Corp.
1400 Providence Hwy.
Norwood,  MA  02062
Applicant Contact NANCY C HALL
Correspondent
Infusaid Corp.
1400 Providence Hwy.
Norwood,  MA  02062
Correspondent Contact NANCY C HALL
Regulation Number880.5965
Classification Product Code
LJT  
Date Received03/26/1990
Decision Date 09/05/1990
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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