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FDA 510(k) Applications for Medical Device Product Code "LGM"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K231256 | Carecubes, Inc. | Carecube Negative Pressure Isolation Chamber | 01/03/2024 |
K080117 | GENTEX CORPORATION | PATIENT ISOLATION UNIT, MODEL G019-1000 | 01/30/2009 |
K022260 | ISOLATION SYSTEMS, INC. | FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS | 08/29/2002 |
K163223 | ISOVAC PRODUCTS, LLC | ORCA (tm) - Operational Rescue Containment Apparatus | 11/02/2017 |