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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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2x2 sponges, non-sterile The Medical Group, Inc. k863760 10/24/1986
bard eska jonas silicone-silver penile prosthesis C.R. Bard, Inc. k864040 10/24/1986
deka jr. Deka Research & Development Corp. k863204 09/03/1986
solarshields Dioptics k862719 08/21/1986
schooltable Mednet, Inc. k862894 08/13/1986
slender regular tampax tampons Tambrands, Inc. k861913 08/12/1986
endoscopic electrosurgical fiberoptic probe Trimedyne, Inc. k861331 08/07/1986
ampu-pak Ammerman Medical Enterprises, Inc. k860511 08/04/1986
compass ct stereotactic adaptation system Stereotactic Medical Systems, Inc. k862220 06/18/1986
iron procedure Data Medical Associates, Inc. k861603 05/23/1986

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