Cleared Traditional

HOOD ESOPHAGEAL PROSTHESIS

K871244 · Hood Laboratories · Gastroenterology & Urology
Apr 1987
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K871244 is an FDA 510(k) clearance for the HOOD ESOPHAGEAL PROSTHESIS, a Prosthesis, Esophageal (Class II — Special Controls, product code ESW), submitted by Hood Laboratories (Pembroke, US). The FDA issued a Cleared decision on April 13, 1987, 17 days after receiving the submission on March 27, 1987. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 878.3610.

Submission Details

510(k) Number K871244 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 1987
Decision Date April 13, 1987
Days to Decision 17 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code ESW — Prosthesis, Esophageal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3610

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