Cleared Traditional

K011500 - MENTOR CONTOUR PROFILE TISSUE EXPANDER
(FDA 510(k) Clearance)

K011500 · Mentor Corp. · General & Plastic Surgery device

Dec 2001

Decision

201d

Days

—

Risk

K011500 is an FDA 510(k) clearance for the MENTOR CONTOUR PROFILE TISSUE EXPANDER. This device is classified as a Tissue Expander And Accessories.

Submitted by Mentor Corp. (Santa Barbara, US). The FDA issued a Cleared decision on December 3, 2001, 201 days after receiving the submission on May 16, 2001.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number	K011500 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 16, 2001
Decision Date	December 03, 2001
Days to Decision	201 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF