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Found 3 results
510(k) Data Aggregation
K Number
K042526Device Name
DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX
Manufacturer
MEDICAL ACTION INDUSTRIES, INC.
Date Cleared
2005-04-25
(220 days)
Product Code
KKX
Regulation Number
878.4370Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL ACTION INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Single Use Disposable OR Towel is typically used for draping, body fluid absorption, and hand drying in an OR application
Device Description
Single Use Disposable OR Towel, Sterile and Non Sterile
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K Number
K042527Device Name
SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107
Manufacturer
MEDICAL ACTION INDUSTRIES, INC.
Date Cleared
2004-11-08
(52 days)
Product Code
HHT
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL ACTION INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use as a diagnostic accessory. A blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
Device Description
Cervical Scraper
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K Number
K022948Device Name
VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L
Manufacturer
MEDICAL ACTION INDUSTRIES, INC.
Date Cleared
2002-11-04
(60 days)
Product Code
HIB
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL ACTION INDUSTRIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vaginal Speculums are single use and shall be used to expose the interior of the vagina.
Device Description
The MAI vaginal speculum is a non-metal (polystyrene), hand held device used to expose the interior of the vagina.
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