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510(k) K935571

DURALASTIC SHEETING by Applied Biomaterial Technologies — Product Code MIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1995
Date Received
November 18, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Elastomer, Silicone Block
Device Class
Class II
Regulation Number
874.3620
Review Panel
SU
Submission Type

Other clearances by Applied Biomaterial Technologies

  • K945552 — DURALASTIC SHEETING (January 31, 1995)
  • K931500 — THE PERMARIDGE MATRIX CHIN (November 17, 1994)
  • K913768 — PEC IMPLANT (February 3, 1992)
  • K902285 — THE MAGNUM CHIN IMPLANT (September 12, 1990)
  • K902284 — ZYMALAR IMPLANT (September 12, 1990)
  • K902283 — THE NAUTILUS NASAL IMPLANT (August 14, 1990)

Other clearances for product code MIB

  • K241150 — MISTI Silicone Implant (July 24, 2024)
  • K223051 — Pre-Formed Silicone Block (February 3, 2023)
  • K222748 — ShiNeo Silicone Implant (December 23, 2022)
  • K200073 — AugMENTA Penile Implant (September 30, 2022)
  • K220760 — Pre-Formed Penile Silicone Block (May 13, 2022)
  • K193392 — BioSiCar Silicone Implant (July 20, 2020)
  • K181387 — Pre-Formed Penile Silicone Block (January 23, 2019)
  • K171851 — SOFTXIL (March 16, 2018)
  • K162624 — Pre-Formed Penile Silicone Block (February 1, 2017)
  • K052505 — CALF IMPLANT, MODEL EC17-X (November 4, 2005)