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Found 3 results
510(k) Data Aggregation
K Number
K990567Device Name
GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH
Manufacturer
GLOBAL HEALTHCARE, INC.
Date Cleared
1999-04-05
(41 days)
Product Code
FRG
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
GLOBAL HEALTHCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The sterilization wrap (pouch) is a device intended to be used to enclose another medical device that is to be sterilized using ethylene oxide or steam by a health care provider. It is intended to allow sterilization via ethylene oxide or steam of the enclosed medical device and also to maintain sterility of the enclosed device until used.
Device Description
Sterilization Wrap (pouch)
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K Number
K954549Device Name
SURGICAL APPAREL
Manufacturer
GLOBAL HEALTHCARE, INC.
Date Cleared
1996-04-18
(199 days)
Product Code
FYC
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
GLOBAL HEALTHCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K953754Device Name
GLOBAL HEALTHCARE FACE MASK
Manufacturer
GLOBAL HEALTHCARE, INC.
Date Cleared
1996-01-26
(168 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
GLOBAL HEALTHCARE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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