Cleared Traditional

SPECIMEN TRAP

K834467 · Microvasive · General Hospital
Feb 1984
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K834467 is an FDA 510(k) clearance for the SPECIMEN TRAP, a Trap, Sterile Specimen (Class II — Special Controls, product code BYZ), submitted by Microvasive (Mchenry, US). The FDA issued a Cleared decision on February 17, 1984, 59 days after receiving the submission on December 20, 1983. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K834467 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 1983
Decision Date February 17, 1984
Days to Decision 59 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