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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K080779
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Irrisept Wound Debridement and Cleansing System. 12 units per case. 2 10/24/2019 FEI # 3005706359
IrriMAX Corporation
Irrisept OR, Finished Bottle Assembly 450 ml STEP 1 2 11/20/2018 FEI # 1417519
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
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