
Debusk Knitting Mills, Div. Deroyal Industries
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DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS is an FDA 510(k)-cleared medical device (K961087) manufactured by Debusk Knitting Mills, Div. Deroyal Industries. 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 May 15, 1996. Regulation: 8.