CREAT BRAND SKIN EXPANDER (K843678) - FDA 510(k) Clearance

K843678 is an FDA 510(k) clearance for the CREAT BRAND SKIN EXPANDER. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Aesthetech Corp. (Paso Robles, US). The FDA issued a Cleared decision on November 6, 1984 after a review of 49 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery 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.

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