Cleared Traditional

K803067 - SURG-FLEX 10 LIGHT
(FDA 510(k) Clearance)

K803067 · Medical Products Development, Inc. · General & Plastic Surgery

Feb 1981

Decision

84d

Days

Class 2

Risk

K803067 is an FDA 510(k) clearance for the SURG-FLEX 10 LIGHT, a Light, Surgical, Instrument (Class II — Special Controls, product code FSQ), submitted by Medical Products Development, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 26, 1981, 84 days after receiving the submission on December 4, 1980. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number	K803067 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 04, 1980
Decision Date	February 26, 1981
Days to Decision	84 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—