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510(k) K853945

CUI RHINOPLASTY IMPLANTS by Cox-Uphuff Intl. — Product Code FZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1985
Date Received
September 24, 1985
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 Cox-Uphuff Intl.

  • K874276 — CUI, VERSAFIL(TM), STE(TM) TISSUE EXPANDER (December 2, 1987)
  • K874342 — LIGATURE CARRIER/PACKER, HYDROXYLAPATITE (November 13, 1987)
  • K873470 — TEMPLATE (September 8, 1987)
  • K865056 — CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER (May 22, 1987)
  • K871200 — CUI NASAL SEPTUM BUTTON (April 15, 1987)
  • K865033 — BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER (January 12, 1987)
  • K854339 — CUI CHIN SIZER (November 15, 1985)
  • K831566 — CUI MAMMARY PROTHESIS SIZER (August 12, 1983)
  • K813394 — DS-7 CLOSED WOUND SUCTION DRAIN SYSTEM (January 22, 1982)
  • K802214 — COS-UPHOFF INT'L DS-5 DRAINAGE SYSTEM (October 23, 1980)

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  • K071018 — MONARCH NASAL IMPLANT (May 25, 2007)
  • K041690 — MONARCH NASAL IMPLANT (February 11, 2005)
  • K021418 — AART NASAL IMPLANT (July 2, 2002)
  • K992242 — PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS (November 22, 1999)
  • K983755 — NASAL DORSAL SERIES (November 20, 1998)
  • K982753 — SEARE BIOMEDICAL NASAL IMPLANTS (September 30, 1998)