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Found 6 results
510(k) Data Aggregation
K Number
K060414Device Name
KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE
Manufacturer
KMI KOLSTER METHODS, INC.
Date Cleared
2006-10-23
(249 days)
Product Code
GAW, GAM
Regulation Number
878.5010Why did this record match?
Applicant Name (Manufacturer) :
KMI KOLSTER METHODS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Featherlift silhouette Suture is indicated for use in mid-face suspension surgery to fixate the cheek sub dermis in an elevated position.
Device Description
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K Number
K043591Device Name
FEATHERLIFT EXTENDED APTOS THREAD
Manufacturer
KMI KOLSTER METHODS, INC.
Date Cleared
2005-03-04
(66 days)
Product Code
GAW
Regulation Number
878.5010Why did this record match?
Applicant Name (Manufacturer) :
KMI KOLSTER METHODS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Featherlift™ Extended Length Aptos Thread is indicated for use in midface suspension surgery to fixate the cheek sub dermis in an elevated position.
Device Description
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K Number
K012236Device Name
STARS2000 POWER CANNULA
Manufacturer
KMI KOLSTER METHODS, INC.
Date Cleared
2001-11-19
(125 days)
Product Code
QPB, MUU
Regulation Number
878.5040Why did this record match?
Applicant Name (Manufacturer) :
KMI KOLSTER METHODS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indication for use for the K.M.I. Kolster Methods Inc. Stars2000 power cannula device is for situations requiring the removal of tissue or fluids from the body during general surgical procedures including suction lipoplasty for the purpose of aesthetic body contouring.
Device Description
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K Number
K010702Device Name
XUB EXTERNAL ULTRASOUND
Manufacturer
KMI KOLSTER METHODS, INC.
Date Cleared
2001-08-09
(154 days)
Product Code
IMI
Regulation Number
890.5300Why did this record match?
Applicant Name (Manufacturer) :
KMI KOLSTER METHODS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K002859Device Name
SSW-STERILE SOLUTION WARMER
Manufacturer
KMI KOLSTER METHODS, INC.
Date Cleared
2000-11-16
(64 days)
Product Code
LHC
Regulation Number
890.5950Why did this record match?
Applicant Name (Manufacturer) :
KMI KOLSTER METHODS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The K.M.I. SSW Sterile Solution Warmer is intended for the administration of sterile solutions at a controlled temperature drawn from containers using K.M.I. DIK system administration set. The "K" pump is also used in conjunction with this device.
Device Description
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K Number
K991203Device Name
IRRIGATION OR INFUSION PUMP K PUMP
Manufacturer
KMI KOLSTER METHODS, INC.
Date Cleared
1999-10-15
(190 days)
Product Code
FRN
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
KMI KOLSTER METHODS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The K.M.I. Irrigation or Infusion pump "K" Pump is intended for the administration of sterile solutions drawn from containers using standard sterile administration sets with a 3/8 diameter silicone peristaltic section. The "K" Pump is intended for the rapid introduction of sterile fluids into the wound site for wound irrigation. The "K" pump may also be used with K.M.I.'s DIK Irrigation System.
Device Description
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