Cleared Traditional

K823793 - ABC BRAND (FDA 510(k) Clearance)

K823793 · Beiersdorf, Inc. · Physical Medicine device
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Jan 1983
Decision
29d
Days
-
Risk

K823793 is an FDA 510(k) clearance for the ABC BRAND.

Submitted by Beiersdorf, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 14, 1983 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Physical Medicine 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Beiersdorf, Inc. devices

Submission Details

510(k) Number K823793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1982
Decision Date January 14, 1983
Days to Decision 29 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -