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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Compression
510(k) Number K070457
Device Name SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB
Applicant
Sun Scientific, LLC
543 Long Hill Ave.
Shelton,  CT  06484
Applicant Contact JOSEPH AZARY
Correspondent
Sun Scientific, LLC
543 Long Hill Ave.
Shelton,  CT  06484
Correspondent Contact JOSEPH AZARY
Regulation Number880.5075
Classification Product Code
MHW  
Date Received02/16/2007
Decision Date 05/16/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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