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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 K912765
Device Name STASIS BUTTON PRSSURE DEVICE
Applicant
ARCH DEVELOPMENT GROUP
9648 OLIVE BLVD., SUITE 411
ST. LOUIS,  MO  63132
Applicant Contact ROBERT A ROTH
Correspondent
ARCH DEVELOPMENT GROUP
9648 OLIVE BLVD., SUITE 411
ST. LOUIS,  MO  63132
Correspondent Contact ROBERT A ROTH
Regulation Number880.5075
Classification Product Code
MHW  
Date Received06/24/1991
Decision Date 08/12/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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