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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K945807
Device Name HOMEVUE WOUND MONITORING SYSTEM
Applicant
Homevue Health Systems, Inc.
23181 Verdugo Dr.
Suite 101
Laguna Hills,  CA  92653
Applicant Contact STEVEN C MILLER
Correspondent
Homevue Health Systems, Inc.
23181 Verdugo Dr.
Suite 101
Laguna Hills,  CA  92653
Correspondent Contact STEVEN C MILLER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/28/1994
Decision Date 08/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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