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510(k) Data Aggregation
K Number
K973128Device Name
OLYMPUS NA-10J-1 ASPIRATION NEEDLE
Manufacturer
OLYMPUS AMERICA, INC.
Date Cleared
1997-11-18
(89 days)
Product Code
FOG
Regulation Number
868.5700Why did this record match?
Product Code :
FOG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Olympus NA-10J-1 Aspiration Needle is specifically designed to be used with the Olympus GF-UM30P ultrasound gastroscope for ultrasonically guided fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract (i.e., pancreatic masses, mediastinal masses, peri-pancreatic masses, and lymph nodes).
Device Description
Olympus NA-10J-1 Aspiration Needle
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K Number
K962182Device Name
BURLEW INFANT HOOD
Manufacturer
PROMEDIC, INC.
Date Cleared
1996-07-15
(39 days)
Product Code
FOG
Regulation Number
868.5700Why did this record match?
Product Code :
FOG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device indicated for patients who need to be placed in an oxygen enriched environment.
Device Description
Disposable Infant hood with drape
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K Number
K955482Device Name
SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION)
Manufacturer
ADVANTAGE MEDICAL SERVICES, INC.
Date Cleared
1996-01-30
(90 days)
Product Code
FOG
Regulation Number
868.5700Why did this record match?
Product Code :
FOG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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