Tepha, Inc.
GalaSHAPE 3D
SKU K161092UPC OOD
In Stock
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IIFDA 510(k) Cleared (K161092)
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Free shipping on orders over $99 · 30-day returns
Tepha, Inc.
Free shipping on orders over $99 · 30-day returns
GalaSHAPE 3D is an FDA 510(k)-cleared medical device (K161092) manufactured by Tepha, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 22, 2016. Regulation: 8.
