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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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leveen needle electrode Radiotherapeutics Corp. k000032 03/30/2000
leveen reflect monopolar/bipolar needle electrode Radiotherapeutics Corp. k011220 07/01/2002
radionics rf disc catheter electrode system Radionics, Inc. k001741 10/23/2000
radiomed source Radiomed Corp. k001070 10/24/2000
radioear re series hearing aids Radioear Corp. k781458 09/07/1978
pocket ultrasonic ophthalmic pachymeter, biometry transducer for pocket Quantel Medical k000554 03/14/2000
fastpack high sensitivity c-reactive protein immunoassay, high sensitivity c-reactive protein calibrator kit, fastpack high sensitivity c-reactive protein controls, fastpack high sensitivity c-reactive protein method verification kit Qualigen, Inc. k141689 01/07/2015
system 82 computerized lung vo. spiro Pulmonary Testing Systems k801918 10/03/1980
c.l.e. acetabular cup Protek, Inc. k870922 10/28/1987
chlorinated powdered latex examination gloves, blue, green Protection Gloves Sdn. Bhd. k011231 06/13/2001

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