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510(k) K070303

SILICONE TISSUE EXPANDER by Specialty Surgical Products — Product Code LCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2007
Date Received
January 31, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tissue Expander And Accessories
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Specialty Surgical Products

  • K140383 — ALLOX2 TISSUE EXPANDERS (October 28, 2014)
  • K984106 — MAMMARY SIZER, MAMMARY PROTHESIS SIZER (February 12, 1999)
  • K983015 — VIRILIS PENILE PROSTHESIS (February 5, 1999)
  • K982258 — MAMMARY SIZER (September 8, 1998)
  • K982065 — STERILE SILICONE EXTERNAL WOUND COVER (August 12, 1998)
  • K982067 — MAGNETIC PORT SILICONE TISSUE EXPANDER (July 13, 1998)
  • K974653 — SILICONE ELASTOMER SHEETING (March 13, 1998)
  • K974654 — SILICONE BLOCKS (February 24, 1998)
  • K974209 — SILICONE TISSUE/INFLATABLE TISSUE EXPANDER (February 6, 1998)
  • K973656 — DISPOSABLE SILICONE EPISTAXIS CATHETER (November 18, 1997)

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  • K211676 — Motiva Flora SmoothSilk Tissue Expander (October 13, 2023)
  • K214124 — AlloX2 Pro Tissue Expanders (June 8, 2023)
  • K221127 — Sientra, inc. Portfinder (May 10, 2023)
  • K180826 — Natrelle 133 Plus MICROCELL Tissue Expander (December 21, 2018)
  • K182335 — CPX 4 Breast Tissue Expander with Smooth Surface (September 25, 2018)
  • K182054 — Natrelle 133S Tissue Expander (August 29, 2018)