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510(k) K961057

DURALASTIC SHEETING II by Rand Scientific Corp. — Product Code MIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1996
Date Received
March 18, 1996
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 Rand Scientific Corp.

  • K963856 — RAND NASAL PACKING (October 18, 1996)
  • K961081 — SPIRIT RIDGE SILICONE CARVING BLOCK (May 22, 1996)
  • K955777 — PMMA CLASIC (May 16, 1996)
  • K961071 — THE MAGNUM CHIN IMPLANT (April 19, 1996)
  • K961080 — MEDIAL MALAR IMPLANT (April 19, 1996)
  • K961072 — PEC IMPLANT (April 19, 1996)
  • K961124 — THE NAUTILUS (April 19, 1996)
  • K955366 — TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS (March 28, 1996)
  • K952165 — TRANS-AIRE RIGID GAS PERMEABLE CONTACT LENS (June 30, 1995)

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)