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510(k) Data Aggregation
K Number
K082349Device Name
JARIT HULKA UTERINE TENACULUM FORCEPS
Manufacturer
J. JAMNER SURGICAL INSTRUMENTS, INC.
Date Cleared
2008-11-21
(98 days)
Product Code
HDC
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
J. JAMNER SURGICAL INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
JARIT® Hulka Uterine Tenaculum Forceps are indicated to stabilize the cervix and manipulate the uterine fundus under direct pelviscopic visualization in women whose uteri are anteverted or retroverted.
Device Description
JARIT Hulka Uterine Tenaculum Forceps are an 11-inch long stainless steel, ring-handled instrument with ratchet closure having a single-tooth hook at the distal end of one arm and a 3.6 mm diameter uterine sound probe at the distal end of the other arm. The device is reusable, sterilizable and packaged non-sterile.
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