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510(k) K982752

SEARE BIOMEDICAL CHIN IMPLANTS by Seare Biomedical Corp. — Product Code FWP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1998
Date Received
August 6, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Chin, Internal
Device Class
Class II
Regulation Number
878.3550
Review Panel
SU
Submission Type

Other clearances by Seare Biomedical Corp.

  • K983630 — SEARE BIOMEDICAL SILICONE RODS (December 11, 1998)
  • K983792 — SEARE BIOMEDICAL SILICONE TISSUE EXPANDER (December 11, 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)
  • K983041 — SEARE BIOMEDICAL SILICONE SHEETING (September 30, 1998)

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