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Found 2 results

510(k) Data Aggregation

K Number

Device Name

BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)

Manufacturer

BSN MEDICAL, INC.

Date Cleared

2013-07-10

(48 days)

Product Code

DWL

Regulation Number

880.5780

Why did this record match?

Applicant Name (Manufacturer) :

BSN MEDICAL, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Compression Class I Mild swelling, tired aching legs, thrombosis prophylaxis, minor varices, post surgery Compression Class II Primary varices, varices with edema, varices with pregnancy; post-sclerotherapy; post venous ulceration Compression class III Secondary varices; severe varices with edema; post-phlebitic syndrome; chronic venous insufficiency; phiebitis; thrombophlebitis and edema

Device Description

Not Found

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K Number

Device Name

ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS

Manufacturer

BSN MEDICAL, INC.

Date Cleared

2012-12-18

(29 days)

Product Code

DWL

Regulation Number

880.5780

Why did this record match?

Applicant Name (Manufacturer) :

BSN MEDICAL, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

For the management of lymphedema and other edema.

Device Description

Not Found

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