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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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single size tendon spacer MEDIST INTERNATIONAL k000019 03/29/2000
modification to isobar spinal system ENCORE ORTHOPEDICS, INC. k000020 02/03/2000
aesculap bone wax AESCULAP, INC. k000021 03/24/2000
hardydisk cefamandole, 30mcg HARDY DIAGNOSTICS k000022 02/17/2000
friendly light er:yag pulsed laser INNOTECH USA, INC. k000023 11/06/2000
apple medical one-touch uterine sampler APPLE MEDICAL CORP. k000026 03/31/2000
insufflation needle, model r65-933 A & A MEDICAL, INC. k000027 04/03/2000
renaflo ii hf 2000 hemofilter MINNTECH CORP. k000028 04/04/2000
stela ut46 and bt45/46 straight tined pacing leads, stela uj45 and bj44/45 j-shaped tined pacing leads ELA MEDICAL, INC. k000029 04/04/2000
sonoace 600 diagnostic ultrasound system MEDISON AMERICA, INC. k000030 01/19/2000

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