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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K053440
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Product Description
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Recall
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FDA Recall
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Recalling Firm
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AMPLATZER Sizing Balloon II, REF 9-SB-24. Sterile EO. AGA Medical Corporation, 682 Mendelssohn Ave... 2 09/03/2008 FEI # 3005334138
AGA Medical Corporation
AMPLATZER Sizing Balloon II, REF 9-SB-034, Sterile EO, AGA Medical Corporation, 5050 Nathan Lane Nor... 2 03/08/2011 FEI # 3005334138
AGA Medical Corporation
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