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510(k) K080158

LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM by Lb Medical LLC — Product Code FZW

K080158 is an FDA 510(k) premarket notification submitted by Lb Medical LLC for the device "LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM". The FDA issued a decision of Substantially Equivalent on May 2, 2008. The device falls under product code FZW (Expander, Surgical, Skin Graft), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2008
Date Received
January 23, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Expander, Surgical, Skin Graft
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances for product code FZW

  • K984448 — BIRCOLL BALLOON DISSECTOR (January 28, 1999)
  • K972109 — SPACEMAKER SURGICALBALLOON DISSECTOR/EXPANDER (November 14, 1997)
  • K936186 — AESCULAP SKIN GRAFT MESHER (March 10, 1994)
  • K904265 — INAMED RUIZ-COHEN INTRAOPERATIVE TISSUE EXPANDER (March 6, 1991)
  • K902349 — SURGITEK INTRA-SPAN INTRAOPERATIVE TISSUE EXPANDER (September 5, 1990)
  • K883303 — MENTOR RAPID-SPAN (TM) TISSUE EXPANDER (August 26, 1988)
  • K874276 — CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER (December 2, 1987)

FDA data resources