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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name chamber, oxygen, topical, extremity
510(k) Number K050156
Device Name WHS-1000 WOUND HEALING SYSTEM
Applicant
IYIA TECHNOLOGIES, INC.
11440 WEST BERNARDO COURT
SUITE 380
SAN DIEGO,  CA  92127
Applicant Contact ALAN DONALD
Correspondent
IYIA TECHNOLOGIES, INC.
11440 WEST BERNARDO COURT
SUITE 380
SAN DIEGO,  CA  92127
Correspondent Contact ALAN DONALD
Regulation Number878.5650
Classification Product Code
KPJ  
Date Received01/24/2005
Decision Date 06/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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