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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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uric acid reagent Ac Biochemical Laboratories, Inc. k822913 12/20/1982
press-o-test Medi-Swiss Corp. k822102 11/24/1982
lifescope ii/four Nihon Kohden America, Inc. k823249 11/24/1982
capd belt American Medical Products, Inc. k822547 09/09/1982
model ah behing-the-ear-hearing aid Dahlberg Electronics, Inc. k821550 06/14/1982
external female urinary incontinence The Healthcare Group Laboratories, Inc. k821172 05/10/1982
#2001 hektoen Biomedica, Inc. k820798 04/08/1982
introducer for endotracheal tube Imed Corp. k820451 03/26/1982
siemens polydoros 800 Siemens Corp. k820112 02/24/1982
document linearity test standards North American Standards k813411 12/18/1981

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