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510(k) K973166

DOW CORNING SILASTIC ELASTOMER Q7-4750 by Technical Products, Inc. — Product Code MIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1997
Date Received
August 25, 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 Technical Products, Inc.

  • K013321 — SILICONE TRACHEAL T-TUBES (June 4, 2002)
  • K973385 — OVAL SHAPES (December 5, 1997)
  • K971472 — SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFO (July 1, 1997)
  • K971613 — SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE (May 22, 1997)
  • K954116 — SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP (November 6, 1995)

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)