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Ethicon Endo-Surgery, LLC
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REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET is an FDA 510(k)-cleared medical device (K103672) manufactured by Ethicon Endo-Surgery, LLC. 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 April 7, 2011. Regulation: 8.