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510(k) K981833

SILIMED NASAL L SHAPED IMPLANT by Silimed, LLC — Product Code FZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1998
Date Received
May 26, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Nose, Internal
Device Class
Class II
Regulation Number
878.3680
Review Panel
SU
Submission Type

Other clearances by Silimed, LLC

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  • K981850 — SILIMED CHIN IMPLANTS (July 9, 1998)
  • K981835 — SILIMED MALAR IMPLANT (July 9, 1998)
  • K981851 — SILIMED SILICONE CARVING BLOCK (July 9, 1998)
  • K980221 — SILIMED NASAL RETAINER (April 2, 1998)
  • K974482 — SILIMED GLUTEAL IMPLANT (February 24, 1998)
  • K974480 — SILIMED CALF IMPLANT (February 24, 1998)

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  • K041690 — MONARCH NASAL IMPLANT (February 11, 2005)
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  • K983755 — NASAL DORSAL SERIES (November 20, 1998)
  • K982753 — SEARE BIOMEDICAL NASAL IMPLANTS (September 30, 1998)