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U.S. Department of Health and Human Services

510(K) Premarket Notification
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Device Name
Sort by Device Name [A-Z]
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Applicant
Sort by PMA Number [0-9]
Sort by PMA Number [9-0]
510(K)
Number
Sort by Decision Date [0-9]
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Decision
Date
Sort by Decision Date [0-9]
Sort by Decision Date [9-0]
behind-the-ear hearing aid Danavox, Inc. k802859 12/31/1980
clostridium difficile agar base Oxoid U.S.A., Inc. k802495 12/18/1980
cybrex lidocaine Abbott Laboratories k802131 10/31/1980
tenckhoff catheter Sil-Med Corp. k801818 10/23/1980
f/ls mca application software Instrumentation Laboratory CO k801456 10/03/1980
p-nitrophenyl phosphate Macomb Chemical Co. k801086 05/28/1980
rionet &/or rion hearing aid mod. hb-67s Rion Acoustic Instruments, Inc. k800738 04/24/1980
micresurgical tray, sm.,med., & lg. Edward Weck, Inc. k800367 03/10/1980
cardiac pacing electrode Medi-Dyne Instruments, Inc. k792379 12/05/1979
herbert bone screw Zimmer, Inc. k792022 10/26/1979

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