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に定める一般的制限および当該製品コードに定められた個別の制限を超えない範囲であれば、届出を行わずに市販することが認められています。","claude-sonnet-5","91d8fd6e72f94fce87f65f2ff2248296d62655c1afcde6f64232f1b211dedacc","2026-08-24T02:33:49.041043+00:00",{"product_code":6,"summary_ja":168,"stats":169,"stats_hash":178,"model_name":164,"created_at":179,"updated_at":179},"本製品コードは届出免除(510(k) 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