Search Results
Found 2 results
510(k) Data Aggregation
K Number
K060465Device Name
PREMIO
Manufacturer
PETERS SURGICAL
Date Cleared
2007-01-17
(329 days)
Product Code
MXW
Regulation Number
878.5010Why did this record match?
Product Code :
MXW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PREMIO® sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, in ophthalmic surgery and in neurological surgery.
Device Description
PREMIO® is a synthetic non-absorbable surgical suture composed of a polyvinylidene fluoride monofilament blue dyed with Phthalocyanine Copper. The suture may be provided with or without pledget.
Ask a Question
K Number
K052953Device Name
NUVANCE* FACIAL REJUVENATION SYSTEM
Manufacturer
ETHICON, INC.
Date Cleared
2006-03-06
(137 days)
Product Code
MXW
Regulation Number
878.5010Why did this record match?
Product Code :
MXW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NUVANCE* Facial Rejuvenation System is intended to fixate subdermal tissue in an elevated position in plastic and reconstructive surgery. The device may be used in areas such as the forehead, midface, jowls and neck.
Device Description
NUVANCE For Face is a sterile implant typically used in minimally invasive face-lift and facial contouring procedures. It consists of a bi-directionally barbed polymer strand with a short and a long straight steel introducer attached at the ends. The device may be pigmented to enhance visibility.
The strand has barbed upper and lower anchoring sections with unbarbed smooth sections adjacent to the steel introducers. Upper and lower anchoring sections are barbed in opposite directions with a small unbarbed section between them. Two sizes and various lengths are available.
Ask a Question
Page 1 of 1