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510(k) K883303

MENTOR RAPID-SPAN (TM) TISSUE EXPANDER by Mentor Corp. — Product Code FZW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1988
Date Received
August 4, 1988
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

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Other clearances for product code FZW

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  • 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)
  • K874276 — CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER (December 2, 1987)