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510(k) K060465

PREMIO by Peters Surgical — Product Code MXW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2007
Date Received
February 22, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Surgical, Nonabsorbable, Poly (Vinylidene Fluoride)
Device Class
Class II
Regulation Number
878.5010
Review Panel
SU
Submission Type

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  • K071281 — UNIRING - ANNULOPLASTY RING WITH SIZERS (August 3, 2007)
  • K060163 — CARDIOFLON, CARDIOXYL (October 11, 2006)
  • K062366 — OPTIME, SINUSORB PGA (October 2, 2006)
  • K052701 — COROLENE (December 13, 2005)

Other clearances for product code MXW

  • K052953 — NUVANCE* FACIAL REJUVENATION SYSTEM (March 6, 2006)