Cleared Traditional

MICROBIOLOGY SPECIMEN BRUSH

K820771 · Mill-Rose Laboratory · Microbiology

May 1982

Decision

41d

Days

Class 2

Risk

About This 510(k) Submission

K820771 is an FDA 510(k) clearance for the MICROBIOLOGY SPECIMEN BRUSH, a Brush, Biopsy, Bronchoscope (non-rigid) (Class II — Special Controls, product code BTG), submitted by Mill-Rose Laboratory (Mchenry, US). The FDA issued a Cleared decision on May 3, 1982, 41 days after receiving the submission on March 23, 1982. This device falls under the Microbiology review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K820771 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 23, 1982
Decision Date	May 03, 1982
Days to Decision	41 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—

Device Classification

Product Code	BTG — Brush, Biopsy, Bronchoscope (non-rigid)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4680
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).