Home / 510(k) Clearances / K865033

510(k) K865033

BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER by Cox-Uphuff Intl. — Product Code LCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1987
Date Received
December 23, 1986
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 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)
  • K854339 — CUI CHIN SIZER (November 15, 1985)
  • 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)

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