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Found 3 results
510(k) Data Aggregation
K Number
K070432Device Name
GENERAL SURGERY DRAPES
Manufacturer
WELMED INC.
Date Cleared
2007-09-24
(223 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
WELMED INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable sterile drapes are used in the operating room as a protective covering, for both patient and operating room staff, from the transfer of body fluids, micro-organisms and particulates.
Drapes provided as sterile and non-sterile.
Non-sterile surgical drapes are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Drapes are to be sold directly to users after EtO sterilization validation to ISO 11135.
Device Description
Not Found
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K Number
K070936Device Name
WELMED HYPODERMIC SYRINGE
Manufacturer
WELMED INC.
Date Cleared
2007-07-16
(104 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
WELMED INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Welmed, Inc. piston syringes is to inject fluids into or withdraw fluids from the body.
Device Description
The Welmed, Inc. Syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer.
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K Number
K070431Device Name
WELMED, INC. SURGICAL GOWNS
Manufacturer
WELMED INC.
Date Cleared
2007-05-24
(100 days)
Product Code
FYA
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
WELMED INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable gowns are used in the OR as a protective covering, for operating room staff, from the transfer of body fluids and particulates.
Gowns provided as sterile and non-sterile.
Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.
Device Description
Not Found
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