Cleared Traditional

4 SURE TM FEEDING TUBES

K921853 · Boston Pacific Medical, Inc. · Gastroenterology & Urology
Jul 1993
Decision
452d
Days
Class 2
Risk

About This 510(k) Submission

K921853 is an FDA 510(k) clearance for the 4 SURE TM FEEDING TUBES, a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Boston Pacific Medical, Inc. (Boston, US). The FDA issued a Cleared decision on July 13, 1993, 452 days after receiving the submission on April 17, 1992. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K921853 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 1992
Decision Date July 13, 1993
Days to Decision 452 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code KNT — Tubes, Gastrointestinal (and Accessories)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5980

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