Cleared Traditional

TIK EXTRAKTOR

K895212 · Instruments of Sweden, Inc. · General & Plastic Surgery

Sep 1989

Decision

40d

Days

Class 1

Risk

About This 510(k) Submission

K895212 is an FDA 510(k) clearance for the TIK EXTRAKTOR, a Forceps (Class I — General Controls, product code HTD), submitted by Instruments of Sweden, Inc. (Stamford, US). The FDA issued a Cleared decision on September 27, 1989, 40 days after receiving the submission on August 18, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K895212 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 18, 1989
Decision Date	September 27, 1989
Days to Decision	40 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—