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510(k) Data Aggregation
K Number
K083424Device Name
BUSSE SURGICAL DRAPE
Manufacturer
BUSSE HOSIPITAL DISPOSABLES
Date Cleared
2009-02-26
(99 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
BUSSE HOSIPITAL DISPOSABLES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Busse Surgical Drape is intended to be used as a protective patient covering, such as to isolate a site of surgical incisions from microbial and other contamination. They are provided sterile using Ethylene Oxide. There are various models of drapes: Non-woven drapes, Tissue Drape, & SMS Drapes with round, oval & square fenestration shapes.
Device Description
Surgical drapes described in this submission are one piece, single use, designed to provide an absorbent sterile barrier & protection from microbial and other contamination. There are various sizes, with & without fenestration, and with & without adhesive strip/patch.
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K Number
K080804Device Name
BUSSE PLASTIC LOR SYRINGE
Manufacturer
BUSSE HOSIPITAL DISPOSABLES
Date Cleared
2008-07-09
(110 days)
Product Code
CAZ
Regulation Number
868.5140Why did this record match?
Applicant Name (Manufacturer) :
BUSSE HOSIPITAL DISPOSABLES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Busse Plastic LOR Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the loss of resistance technique; it will be filled with air and/or saline during use. The Busse Plastic LOR syringe is not intended for injection or aspiration. The syringe will be sold sterile individually packaged and as part of a sterile kit.
Device Description
The LOR plastic syringe is a single use device which is sold as sterile individually packaged and sterile packaged inside a kit/procedure tray. The syringe will be available in luer lock and luer slip.
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