Cleared Traditional

K902121 - LAKE GASTROSTOMY TUBE
(FDA 510(k) Clearance)

K902121 · Lake Medical Products, Inc. · Gastroenterology & Urology

Jul 1990

Decision

77d

Days

Class 2

Risk

K902121 is an FDA 510(k) clearance for the LAKE GASTROSTOMY TUBE, a Tube, Gastro-enterostomy (Class II — Special Controls, product code KGC), submitted by Lake Medical Products, Inc. (St. Louis, US). The FDA issued a Cleared decision on July 27, 1990, 77 days after receiving the submission on May 11, 1990. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number	K902121 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 11, 1990
Decision Date	July 27, 1990
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	—