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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilant, Medical Devices
510(k) Number K061356
Device Name POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6
Applicant
Advanced Infusion, Inc.
920 E. University Dr.
Suite D202
Tempe,  AZ  85281
Applicant Contact JAMES CHRISTENSEN
Correspondent
Advanced Infusion, Inc.
920 E. University Dr.
Suite D202
Tempe,  AZ  85281
Correspondent Contact JAMES CHRISTENSEN
Regulation Number880.6885
Classification Product Code
MED  
Date Received05/15/2006
Decision Date 07/03/2006
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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