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510(k) K983792

SEARE BIOMEDICAL SILICONE TISSUE EXPANDER by Seare Biomedical Corp. — Product Code LCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1998
Date Received
October 27, 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 Seare Biomedical Corp.

  • K983630 — SEARE BIOMEDICAL SILICONE RODS (December 11, 1998)
  • K983041 — SEARE BIOMEDICAL SILICONE SHEETING (September 30, 1998)
  • K982762 — SEARE BIOMEDICAL PECTORALIS IMPLANT (September 30, 1998)
  • K983043 — SEARE BIOMEDICAL SILICONE BLOCK (September 30, 1998)
  • K982763 — SEARE BIOMEDICAL MALAR IMPLANTS (September 30, 1998)
  • K982753 — SEARE BIOMEDICAL NASAL IMPLANTS (September 30, 1998)
  • K982752 — SEARE BIOMEDICAL CHIN IMPLANTS (September 30, 1998)

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