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510(k) K971480

DURALASTIC I AND DURALASTIC II by Allied Biomedical Corp. — Product Code MIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1997
Date Received
April 23, 1997
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 Allied Biomedical Corp.

  • K982051 — KELOCATE SHEETING (August 5, 1998)
  • K971478 — DURALASTIC ANATOMICAL CHIN IMPLANTS (July 18, 1997)
  • K971479 — DURALASTIC ANATOMICAL MALAR IMPLANTS (July 18, 1997)
  • K971481 — DURALASTIC ANATOMICAL NASAL IMPLANTS (July 18, 1997)
  • K955368 — DURALASTIC I (February 8, 1996)
  • K955370 — DURALASTIC II (February 8, 1996)
  • K955433 — DURALASTIC SILICONE TUBING (January 26, 1996)
  • K954413 — KELOCOTE (November 29, 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)