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510(k) Data Aggregation
K Number
K971483Device Name
SECURE-WRAP (TM) STERILIZATION WRAP
Manufacturer
AMERICAN THRESHOLD INDUSTRIES, INC.
Date Cleared
1997-06-24
(62 days)
Product Code
FRG
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN THRESHOLD INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also maintain sterility of the enclosed device until used. It is intended for use with either steam or ethylene oxide sterilization methods.
Device Description
Secure-Wrap® Sterilization Wrap
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K Number
K953878Device Name
BOUFFANT CAP
Manufacturer
AMERICAN THRESHOLD INDUSTRIES, INC.
Date Cleared
1996-01-05
(142 days)
Product Code
FYF
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN THRESHOLD INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K953879Device Name
SURGEON'S CAP
Manufacturer
AMERICAN THRESHOLD INDUSTRIES, INC.
Date Cleared
1996-01-05
(142 days)
Product Code
FYF
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN THRESHOLD INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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