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510(k) K974209

SILICONE TISSUE/INFLATABLE TISSUE EXPANDER by Specialty Surgical Products, Inc. — Product Code LCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 1998
Date Received
November 10, 1997
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 Specialty Surgical Products, Inc.

  • K140383 — ALLOX2 TISSUE EXPANDERS (October 28, 2014)
  • K070303 — SILICONE TISSUE EXPANDER (June 22, 2007)
  • K984106 — MAMMARY SIZER, MAMMARY PROTHESIS SIZER (February 12, 1999)
  • K983015 — VIRILIS PENILE PROSTHESIS (February 5, 1999)
  • K982258 — MAMMARY SIZER (September 8, 1998)
  • K982065 — STERILE SILICONE EXTERNAL WOUND COVER (August 12, 1998)
  • K982067 — MAGNETIC PORT SILICONE TISSUE EXPANDER (July 13, 1998)
  • K974653 — SILICONE ELASTOMER SHEETING (March 13, 1998)
  • K974654 — SILICONE BLOCKS (February 24, 1998)
  • K973656 — DISPOSABLE SILICONE EPISTAXIS CATHETER (November 18, 1997)

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