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510(k) K913882

ZARA SILICONE BLOCK by Byron Medical — Product Code MIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1992
Date Received
August 29, 1991
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

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  • K980738 — PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILT (June 16, 1998)
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  • K973133 — BIG BAG 3000 PRESSURE INFUSOR (September 12, 1997)
  • K934179 — DISPOSABLE BAG DECANTER (May 23, 1994)
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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)