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FDA 510(k), K122609, VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003; VASCULAIRE SLEEVE (FOOT & CALF) MODEL FLS-0002; VASCULAIRE SLEEVE (CALF) F
FDA 510(k), K122609, VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003; VASCULAIRE SLEEVE (FOOT & CALF) MODEL FLS-0002; VASCULAIRE SLEEVE (CALF) F
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510(K) Number: K122609
Device Name: VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003; VASCULAIRE SLEEVE (FOOT & CALF) MODEL FLS-0002; VASCULAIRE SLEEVE (CALF) F
Manufacturer: VENOUS HEALTH SYSTEMS, INC.
Device Classification Name: sleeve, limb, compressible
Regulation Number: 870.5800
Classification Product Code: JOW
Date Received: 08/27/2012
Decision Date: 12/21/2012
Regulation Medical Specialty: Cardiovascular
Device Name: VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003; VASCULAIRE SLEEVE (FOOT & CALF) MODEL FLS-0002; VASCULAIRE SLEEVE (CALF) F
Manufacturer: VENOUS HEALTH SYSTEMS, INC.
Device Classification Name: sleeve, limb, compressible
Regulation Number: 870.5800
Classification Product Code: JOW
Date Received: 08/27/2012
Decision Date: 12/21/2012
Regulation Medical Specialty: Cardiovascular
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