Search Results
Found 3 results
510(k) Data Aggregation
K Number
K970966Device Name
COMFORT CATH CHOICE MALE EXTERNAL CATHETERManufacturer
Date Cleared
1997-04-22
(36 days)
Product Code
Regulation Number
876.5250Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
SIERRA 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
K Number
K962413Manufacturer
Date Cleared
1996-07-15
(24 days)
Product Code
Regulation Number
876.5250Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
SIERRA 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
K Number
K962384Manufacturer
Date Cleared
1996-07-15
(25 days)
Product Code
Regulation Number
876.5250Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Applicant Name (Manufacturer) :
SIERRA 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
Page 1 of 1