Cleared Traditional

TISSUE/POLYP TRAP SYSTEM

K902883 · Triton Technology, Inc. · General Hospital
Sep 1990
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K902883 is an FDA 510(k) clearance for the TISSUE/POLYP TRAP SYSTEM, a Trap, Sterile Specimen (Class II — Special Controls, product code BYZ), submitted by Triton Technology, Inc. (Salem, US). The FDA issued a Cleared decision on September 12, 1990, 72 days after receiving the submission on July 2, 1990. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K902883 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 1990
Decision Date September 12, 1990
Days to Decision 72 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

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