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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Portable, Aspiration (Manual Or Powered)
510(k) Number K040239
Device Name SUPRAFLOW CONSOLE
Applicant
Neomedix Corp.
27452 Calle Arroyo
San Juan Capistrano,  CA  92675 -2748
Applicant Contact SOHEILA MIRHASHEMI
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607 -9526
Correspondent Contact MARC M MOUSER
Regulation Number878.4780
Classification Product Code
BTA  
Date Received02/02/2004
Decision Date 02/17/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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