Cleared Traditional

MUCOUS SPECIMEN TRAP

K913643 · Medical Device Inspection Co., Inc. · General Hospital
Oct 1991
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K913643 is an FDA 510(k) clearance for the MUCOUS SPECIMEN TRAP, a Trap, Sterile Specimen (Class II — Special Controls, product code BYZ), submitted by Medical Device Inspection Co., Inc. (Great Neck, US). The FDA issued a Cleared decision on October 10, 1991, 57 days after receiving the submission on August 14, 1991. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K913643 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 1991
Decision Date October 10, 1991
Days to Decision 57 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