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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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510(K)
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Decision
Date
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mersilk black silk braided non-absorbable suture, usp JOHNSON & JOHNSON MEDICAL (CHINA) LTD. k012124 09/19/2001
avante micro crystal system JENERIC/PENTRON, INC. k012231 08/23/2001
bayer advia ims system; c-reactive protein system BAYER CORP. k012337 12/06/2001
propaq encore models 202, 204, 206; propaq cs models 242, 244, 246 WELCH ALLYN PROTOCOL, INC. k012451 08/20/2001
datex-ohmeda s/5 device interfacing solution, n-disxxxx DATEX-OHMEDA k012531 11/02/2001
clearmedical/nellcor oxisensor ii, pediatric, model d-20 CLEAR MEDICAL, INC. k012622 07/03/2002
symphony graft delivery system (gds) DEPUY ACROMED k012738 11/14/2001
recording and stimulating electrode RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP k012850 11/19/2001
biogenex monoclonal anti-progesterone receptor BIOGENEX LABORATORIES k012960 03/08/2002
neptune waste management ststem STRYKER INSTRUMENTS k012991 11/29/2001

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