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510(k) K112534

LIFECELL TISSUE EXPANDER by Lifecell Corp. — Product Code LCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2012
Date Received
September 1, 2011
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 Lifecell Corp.

  • K130817 — LTN - LAPAROSCOPIC SURGICAL MESH (April 17, 2013)
  • K121289 — LTM-LABAROSCOPIC SURGICAL MESH (August 3, 2012)
  • K082176 — LTM-BPS SURGICAL MESH (November 14, 2008)
  • K082103 — LTM WOUND DRESSING (October 8, 2008)
  • K080353 — LTM-T SURGICAL MESH (April 3, 2008)
  • K071986 — LTM-RC SURGICAL MESH (October 19, 2007)
  • K070560 — LRTM SURGICAL MESH (June 11, 2007)
  • K061208 — LIFECELL DURAL SUBSTITUTE MATRIX (January 3, 2007)
  • K052735 — ALLOCRAFT DBM (December 28, 2005)

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  • K241918 — MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander (August 2, 2024)
  • 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)