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Found 4 results
510(k) Data Aggregation
K Number
K972187Device Name
BOUFFANT CAP
Manufacturer
AMERICAN SEAL CO.
Date Cleared
1997-09-09
(91 days)
Product Code
KKX, DAT
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN SEAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bouffant Cap is a device intended to be worn by hospital personnel during procedures to protect both the patient and the hospital personnel from transfer of microorganisms, body fluids and particulate materials.
Device Description
Bouffant Cap
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K Number
K972227Device Name
SHOE COVER
Manufacturer
AMERICAN SEAL CO.
Date Cleared
1997-09-09
(88 days)
Product Code
FYF
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN SEAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Shoe Cover is a device intended to be worn by hospital personnel from transfer of procedures to protect both the patient and the hospital personnel from transfer of materials.
Device Description
Shoe Cover
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K Number
K970814Device Name
NON-STERILE ISOLATION GOWN
Manufacturer
AMERICAN SEAL CO.
Date Cleared
1997-05-27
(82 days)
Product Code
FYC
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN SEAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K964358Device Name
AMSEAL SURGICAL FACE MASK
Manufacturer
AMERICAN SEAL CO.
Date Cleared
1997-02-14
(105 days)
Product Code
FXX
Regulation Number
878.4040Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN SEAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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