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510(k) K042054

SILIMED PECTORAL IMPLANT by Silimed, Inc. — Product Code MIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2005
Date Received
July 30, 2004
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, Inc.

  • K974479 — SILIMED VAGINAL STENT (August 5, 1998)
  • K981852 — SILIMED TISSUE EXPANDER (August 5, 1998)
  • K981851 — SILIMED SILICONE CARVING BLOCK (July 9, 1998)
  • K981850 — SILIMED CHIN IMPLANTS (July 9, 1998)
  • K981835 — SILIMED MALAR IMPLANT (July 9, 1998)
  • K981833 — SILIMED NASAL L SHAPED IMPLANT (June 26, 1998)
  • K980221 — SILIMED NASAL RETAINER (April 2, 1998)
  • K974482 — SILIMED GLUTEAL IMPLANT (February 24, 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)