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510(k) Data Aggregation
K Number
K954788Device Name
EUREDUC PNEUMATIC DRAINAGE SYSTEM
Manufacturer
Date Cleared
1996-10-28
(376 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
EUREDUC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EUREDUC TP05 is intended for:
- Lymphedema of lower extremities; post surgical or congenital;
- Postmastectomy lymphedema ;
- Pre, intra, post phases of surgery.
Device Description
EUREDUC TP05 is comprised of: a pneumatic unit in a metal casing with - a microprocessor controlled pump; - a control panel - a range of garments connectable to the unit: - leg boots; - arm sleeves;
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K Number
K960902Device Name
EUREDUC PNEUMATIC DRAINAGE SYSTEM MODEL TP03
Manufacturer
Date Cleared
1996-09-26
(205 days)
Product Code
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
EUREDUC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EUREDUC TP03 is intended for :
- Lymphedema of lower extremities; post surgical or congenital ;
- Postmastectomy lymphedema ;
- Dysfunction of the muscle pump ;
- Pre, post phases of surgery.
Device Description
a pneumatic unit in a plastic casing with :
- a microprocessor controlled pump;
- a control panel
- a range of garments connectable to the unit:
- leg boots;
- arm sleeves;
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