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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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scotchbond 2 adhesive w/scotchprep dentin primer 3M Company k872279 07/02/1987
insufflation needle, model r65-933 A & A Medical, Inc. k000027 04/03/2000
tacker, model r65-933 A & A Medical, Inc. k003949 07/25/2001
rocket intrauterine sound A & A Medical, Inc. k883806 10/31/1988
commview system A T & T Technologies, Inc. k862715 10/16/1986
abbott imx hcg Abbott Laboratories k880070 03/24/1988
imx ferritin Abbott Laboratories k881345 05/11/1988
perclose vascular suture delivery device Abbott Vascular, Inc. k001703 10/03/2000
radixact treatment delivery system Accuray Incorporated k161146 06/24/2016
acme spine system - series 6000, 7000, monoaxial and polyaxial screw system Acme Spine, LLC k001044 11/03/2000

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