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510(k) K241150

MISTI Silicone Implant by Keosan Trading Co. — Product Code MIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2024
Date Received
April 25, 2024
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 Keosan Trading Co.

  • K232593 — FITme Customized Silicone Implant (November 22, 2023)

Other clearances for product code MIB

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  • 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)
  • K052504 — GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X (November 4, 2005)