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510(k) K854339

CUI CHIN SIZER by Cox-Uphuff Intl.

K854339 is an FDA 510(k) premarket notification submitted by Cox-Uphuff Intl. for the device "CUI CHIN SIZER". The FDA issued a decision of Substantially Equivalent on November 15, 1985. Cox-Uphuff Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 1985
Date Received
October 28, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • K853945 — CUI RHINOPLASTY IMPLANTS (October 18, 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)

FDA data resources