
Standard Bariatrics, Inc.
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Standard Staple-Line Reinforcement (SSLR23) is an FDA 510(k)-cleared medical device (K231603) manufactured by Standard Bariatrics, 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 October 5, 2023. Regulation: 8.