Cleared Traditional

K840266 - K-FLEX OSTOMY POUCH (FDA 510(k) Clearance)

K840266 · Coloplast A/S · Gastroenterology & Urology device
Jan 1984
Decision
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Risk

K840266 is an FDA 510(k) clearance for the K-FLEX OSTOMY POUCH..

Submitted by Coloplast A/S (Mchenry, US). The FDA issued a Cleared decision on January 23, 1984.

This device falls under the Gastroenterology & Urology FDA review panel.

Submission Details

510(k) Number K840266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received January 23, 1984
Decision Date January 23, 1984
Days to Decision —
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

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