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510(k) K981851

SILIMED SILICONE CARVING BLOCK by Silimed, LLC — Product Code MIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1998
Date Received
May 26, 1998
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)
  • K974479 — SILIMED VAGINAL STENT (August 5, 1998)
  • K981852 — SILIMED TISSUE EXPANDER (August 5, 1998)
  • K981835 — SILIMED MALAR IMPLANT (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)
  • K974482 — SILIMED GLUTEAL 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)