Cleared Traditional

SEBUTAPE (K840096) - FDA 510(k) Clearance

K840096 · Cuderm Corp. · Chemistry device
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Aug 1984
Decision
205d
Days
-
Risk

K840096 is an FDA 510(k) clearance for the SEBUTAPE.

Submitted by Cuderm Corp. (Walker, US). The FDA issued a Cleared decision on August 2, 1984 after a review of 205 days - an extended review cycle.

This device falls under the Chemistry FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K840096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1984
Decision Date August 02, 1984
Days to Decision 205 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 88d · This submission: 205d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -