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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Microwave, Hair Removal
510(k) Number K010589
Device Name MICROWAVAE DELIVERY SYSTEM #MW2000
Applicant
Mw Medical, Inc.
3722 Ave. Sausalito
Irvine,  CA  92606
Applicant Contact GREG HOLLAND
Correspondent
Mw Medical, Inc.
3722 Ave. Sausalito
Irvine,  CA  92606
Correspondent Contact GREG HOLLAND
Regulation Number878.4400
Classification Product Code
MWY  
Date Received02/27/2001
Decision Date 03/19/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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