Cleared Traditional

HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES

K873742 · Hood Laboratories · General & Plastic Surgery

Oct 1987

Decision

15d

Days

Class 2

Risk

About This 510(k) Submission

K873742 is an FDA 510(k) clearance for the HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES, a Prosthesis, Tracheal, Preformed/molded (Class II — Special Controls, product code NWA), submitted by Hood Laboratories (Pembroke, US). The FDA issued a Cleared decision on October 1, 1987, 15 days after receiving the submission on September 16, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3720.

Submission Details

510(k) Number	K873742 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 1987
Decision Date	October 01, 1987
Days to Decision	15 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—

Device Classification

Product Code	NWA — Prosthesis, Tracheal, Preformed/molded
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.3720
Definition	The Device Is Intended To Provide Support To Weakened Or Constricting Airway Walls.