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510(k) K974482

SILIMED GLUTEAL IMPLANT by Silimed, LLC — Product Code MIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1998
Date Received
November 26, 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 Silimed, LLC

  • K042054 — SILIMED PECTORAL IMPLANT (February 23, 2005)
  • K981852 — SILIMED TISSUE EXPANDER (August 5, 1998)
  • K974479 — SILIMED VAGINAL STENT (August 5, 1998)
  • K981835 — SILIMED MALAR IMPLANT (July 9, 1998)
  • K981851 — SILIMED SILICONE CARVING BLOCK (July 9, 1998)
  • K981850 — SILIMED CHIN IMPLANTS (July 9, 1998)
  • K981833 — SILIMED NASAL L SHAPED IMPLANT (June 26, 1998)
  • K980221 — SILIMED NASAL RETAINER (April 2, 1998)
  • K974480 — SILIMED CALF IMPLANT (February 24, 1998)

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)