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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K070463
Device Name REVERA WOUND CARE, MODEL MDW0060
Applicant
Revalesio Corporation
5102 20th St. E.
Bldg. 100
Tacoma,  WA  98424
Applicant Contact GREG J ARCHAMBEAU
Correspondent
Revalesio Corporation
5102 20th St. E.
Bldg. 100
Tacoma,  WA  98424
Correspondent Contact GREG J ARCHAMBEAU
Classification Product Code
FRO  
Date Received02/16/2007
Decision Date 05/07/2008
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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