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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K894614
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Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70. 2 12/23/2005 Smiths Medical ASD, Inc.
Bivona brand Adjustable Hyperflex Tracheostomy Tube, Pediatric, cuffless; catalog # 60HA40. 2 06/12/2003 Portex, Inc
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