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U.S. Department of Health and Human Services

Medical Device Recalls

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510(K) Number: K153533
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Product Description
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FDA Recall
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Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04... 2 06/15/2023 FEI # 3000718472
Galt Medical Corporation
Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16 2 06/15/2023 FEI # 3000718472
Galt Medical Corporation
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