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510(k) K981852

SILIMED TISSUE EXPANDER by Silimed, LLC — Product Code LCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1998
Date Received
May 26, 1998
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 Silimed, LLC

  • K042054 — SILIMED PECTORAL IMPLANT (February 23, 2005)
  • K974479 — SILIMED VAGINAL STENT (August 5, 1998)
  • K981851 — SILIMED SILICONE CARVING BLOCK (July 9, 1998)
  • K981850 — SILIMED CHIN IMPLANTS (July 9, 1998)
  • K981835 — SILIMED MALAR IMPLANT (July 9, 1998)
  • K981833 — SILIMED NASAL L SHAPED IMPLANT (June 26, 1998)
  • K980221 — SILIMED NASAL RETAINER (April 2, 1998)
  • K974480 — SILIMED CALF IMPLANT (February 24, 1998)
  • K974482 — SILIMED GLUTEAL IMPLANT (February 24, 1998)

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