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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
cybrex lidocaine Abbott Laboratories k802131 10/31/1980
dacomed corp. eska-herrman voice prosthesis Dacomed Corp. k854118 03/17/1986
dahlberg model lp behind-the-ear hearing aid Dahlberg Electronics, Inc. k896159 01/22/1990
danam vector-8+ Danam Electronics k892205 06/13/1989
datacaptor Capsule Technologie k013019 12/18/2001
db precision implant system Driskell Bioengineering k853788 10/31/1985
db push-pull hearing aid Midwest City Hearing Aid Center k953036 07/21/1995
degall laparoscopic gallbladder extractor Surgicon, Inc. k021747 08/15/2002
deluxe adjustable height ultrasound table Biodan Medical Systems, Ltd. k922604 10/20/1992

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