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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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custom personal ear - cpe Qualitone k911497 04/19/1991
puritan-bennett nasal cpap mask Puritan-Bennett k942246 07/06/1994
protologic model ser-1 Protologic, Inc. k894936 01/22/1990
myotest nerve stimulator Prothia USA, Inc. k823583 12/30/1982
fibergraft™ bg putty gps bone graft substitute fibergraft™ bg putty bone graft substitute fibergraft™ aeridyan™ matrix bone graft substitute fibergraft™ bg matrix bone graft substitute Prosidyan, Inc. k253147 10/22/2025
ft model table w/electric hi lo option e Pro Med Mfg., Inc. k925563 05/26/1993
privatan home tanning center Privatan, Inc. k852290 06/21/1985
inclusive® titanium abutments compatible with: neoss® proactive® narrow, neoss® proactive® standard, mis® seven®, zimmer® eztetic® implant systems Prismatik Dentalcraft, Inc. k231097 11/14/2023
sunrunner te-777 Pride Health Care, Inc. k923193 07/17/1992
port-a-trac Port-A-Trac Co. k861554 06/19/1986

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