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Found 6 results
510(k) Data Aggregation
K Number
K964827Device Name
PROD. NO. 01-132 - SUTURE REMOVAL KITManufacturer
Date Cleared
1997-02-14
(74 days)
Product Code
Regulation Number
878.4800Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
CONTINENTAL MEDICAL LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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K Number
K963234Device Name
STAPLE REMOVAL KITManufacturer
Date Cleared
1996-10-21
(63 days)
Product Code
Regulation Number
878.4760Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
CONTINENTAL MEDICAL LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K963443Device Name
PROD. NO. 02-031 - LACERATION TRAYManufacturer
Date Cleared
1996-10-17
(48 days)
Product Code
Regulation Number
878.4370Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
CONTINENTAL MEDICAL LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K962078Manufacturer
Date Cleared
1996-10-11
(136 days)
Product Code
Regulation Number
868.5800Type
TraditionalPanel
AnesthesiologyReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
CONTINENTAL MEDICAL LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K954728Device Name
PROD NO. 01-1694 - 4X4 FOAM DRESSINGManufacturer
Date Cleared
1996-09-23
(346 days)
Product Code
Regulation Number
880.5090Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
CONTINENTAL MEDICAL LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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K Number
K962073Manufacturer
Date Cleared
1996-06-21
(24 days)
Product Code
Regulation Number
876.5130Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
CONTINENTAL MEDICAL LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
Ask a Question
Ask a specific question about this device
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