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510(k) K984448

BIRCOLL BALLOON DISSECTOR by Wells Johnson Co. — Product Code FZW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1999
Date Received
December 14, 1998
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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  • K945876 — WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (December 4, 1995)
  • K945500 — WELLS JOHNSON FIXATION SYSTEM (September 21, 1995)
  • K951519 — WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (June 14, 1995)
  • K945877 — WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT (March 2, 1995)
  • K945805 — WELLS JOHNSON WECO MONOPOLAR/FRAZIER SUCTION PROBE (December 13, 1994)
  • K854068 — EXTERNAL MECHANICAL FASTENER (November 22, 1985)
  • K843188 — WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP (September 20, 1984)
  • K832274 — ASPIRATOR (October 20, 1983)

Other clearances for product code FZW

  • K080158 — LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM (May 2, 2008)
  • 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)