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510(k) Data Aggregation
K Number
K020718Device Name
SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE
Manufacturer
PRECISION DYNAMICS CORP.
Date Cleared
2002-06-03
(90 days)
Product Code
HFW
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
PRECISION DYNAMICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Securline Umbilical Cord Clamp is used to clamp over the umbilical cord of a newborn at delivery. The device is used to hold the cord securely and prevent blood loss and seepage as the curd dries and shrinks after the birth.
Device Description
The Securline® Umbilical Cord Clamp is a single use, disposable, molded plastic device, unit packaged, (sterile) or bulk packaged (nonsterile).
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K Number
K994353Device Name
SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565
Manufacturer
PRECISION DYNAMICS CORP.
Date Cleared
2000-03-22
(90 days)
Product Code
HFM
Regulation Number
884.2720Why did this record match?
Applicant Name (Manufacturer) :
PRECISION DYNAMICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product is to be used in a labor and delivery environment to secure a uterine contraction monitor to the mother's abdomen. The monitors are used to track contractions and baby's heartbeat rate. Two styles of straps are available. The first contains a buttonhole and the second contains Velcro slots on each end (watchlike). Therefore, one style of strap contains multiple "button holes" for adjustment and the second style of strap is made with Velcro hook and loop for adjustment and securing.
Device Description
The straps are made of stretch fabric material and intended to be single-patient use. Both types of straps are packaged in pairs (one pink, one blue) shrink-wrapped and are available in quantities of fifty (50) pairs per box.
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K Number
K994263Device Name
SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540
Manufacturer
PRECISION DYNAMICS CORP.
Date Cleared
2000-01-24
(38 days)
Product Code
HFW
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
PRECISION DYNAMICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Securline® Umbilical Cord Clamp Clipper is used to cut the umbilical cord clamp off a newborn's umbilical cord. The clipper jaws are placed over the "hinge" area of the umbilical cord clamp. Once appropriately located and engaged, pressure is applied to the clipper grips and the hinge is cut in half, removed, and disposed of properly.
Device Description
Precision Dynamics Corporation purchases the packaged umbilical cord clamp clipper (non-sterile) from DeRoyal Industries. Precision Dynamics Corporation upon receipt of the non-sterile finished product from DeRoyal Industries plans to distribute this device as the Securline ® Umbilical Cord Clamp Clipper.
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K Number
K990737Device Name
'ECURLINE UMBILICAL CORD CLAMP #3500
Manufacturer
PRECISION DYNAMICS CORP.
Date Cleared
1999-04-06
(32 days)
Product Code
HFW
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
PRECISION DYNAMICS CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Securline Umbilical Cord Clamp is used to clamp over the umbilical cord of a Newborn at delivery. The device is used to hold the cord securely and prevent blodd loss and seepage as the cord dries and shrinks after the birth.
Device Description
Precision Dynamics Corporation purchases the umbilical cord clamp (non-sterile) from Alpha Unlimited, Inc (refer to the 510k K894646) and then contracts the packaging and sterilization through ARMM, Inc. ARMM, Inc. packages the umbilical cord clamp in a plastic/film pouch and contract sterilizes the packaged product per Precision Dynamics Corporation specifications. Precision Dynamics Corporation upon receipt of the sterile finished released product from ARMM plans to distribute the Securline ® Cord Clamp.
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