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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
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Applicant
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510(K)
Number
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Decision
Date
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cardiovascular instruments-various Edward Weck, Inc. k791710 09/12/1979
ventre/sep digoxin radioimmunoassay kit Ventrex Laboratories, Inc. k791355 08/10/1979
aerosol mouthpiece no. m-091 Mem Medical, Inc. k790932 05/21/1979
exeter lip seal Exeter Medical Labs, Inc. k790554 04/10/1979
2 velcro splint strap Fred Sammons, Inc. k790182 02/15/1979
angioskip Siemens Corp. k781991 12/07/1978
shiley cricothyrotomy tube Shiley, Inc. k781639 10/24/1978
dental x-ray unit heliodent 70 Siemens Corp. k781288 09/11/1978
electrosurgical grounding pad cable Johnson & Johnson Professionals, Inc. k780924 06/22/1978
kova trol iii Icl Scientific k780482 05/03/1978

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