Cleared Traditional

K922402 - 4 SURE TM ENTERAL FEEDING BAG
(FDA 510(k) Clearance)

K922402 · Boston Pacific Medical, Inc. · Gastroenterology & Urology

Mar 1994

Decision

673d

Days

Class 2

Risk

K922402 is an FDA 510(k) clearance for the 4 SURE TM ENTERAL FEEDING BAG, a Tube, Feeding (Class II — Special Controls, product code FPD), submitted by Boston Pacific Medical, Inc. (Boston, US). The FDA issued a Cleared decision on March 25, 1994, 673 days after receiving the submission on May 21, 1992. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number	K922402 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 21, 1992
Decision Date	March 25, 1994
Days to Decision	673 days
Submission Type	Traditional
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement