Cleared Traditional

ELECTROMEDICS TISSUE TRAP/ #TT280

K925412 · Electromedics, Inc. · General Hospital
Feb 1993
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K925412 is an FDA 510(k) clearance for the ELECTROMEDICS TISSUE TRAP/ #TT280, a Trap, Sterile Specimen (Class II — Special Controls, product code BYZ), submitted by Electromedics, Inc. (Englewood, US). The FDA issued a Cleared decision on February 5, 1993, 102 days after receiving the submission on October 26, 1992. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K925412 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 1992
Decision Date February 05, 1993
Days to Decision 102 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code BYZ — Trap, Sterile Specimen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740