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510(k) K903448

SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER by Medical Engineering Corp. — Product Code LCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1991
Date Received
July 31, 1990
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 Medical Engineering Corp.

  • K934141 — STAND ALONE CYSTOMETROGRAM (November 18, 1993)
  • K905289 — SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT (March 13, 1991)
  • K902773 — SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SET (July 16, 1990)
  • K884746 — SURGITEK FLAT T-SPAN (August 10, 1989)
  • K883274 — SURGITEK (R) UROFLOW SYSTEM (February 8, 1989)
  • K881736 — SURGITEK CO2 DELIVERY SYSTEM (August 11, 1988)
  • K880801 — SURGITEK FLEXIBLE URETEROSCOPE SU-7 & SU-9 (May 26, 1988)
  • K880802 — SURGITEK ARTICULATING URETEROSCOPE MODEL SU-11 (May 26, 1988)
  • K842748 — SURGITEK RECONSTRUC-NIPPLE PROSTHESIS (September 26, 1984)
  • K832043 — SURGIKEK PENILE PROSTHESIS TAIL EXTEND (October 20, 1983)

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