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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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sterile piston syringe ABBOTT LABORATORIES k002717 01/08/2001
bio-absorbable corkscrew model ar-1920b ARTHREX, INC. k003227 01/08/2001
2010 plus holter for windows AGILENT TECHNOLOGIES k003763 01/05/2001
monarch ii iol delivery system ALCON RESEARCH, LTD. k003768 01/05/2001
gp general purpose drainage set, mini-pigtail drainage catheter with locking pigtail, gp general purpose drainage cathe URESIL CORP. k003753 01/04/2001
biosorbfx tack and biosorbpdx tack bioabsorbable fixation fastener, used with plates BIONX IMPLANTS, INC. k003756 01/03/2001
modification to ebi spinelink system EBI, L.P. k003764 01/02/2001
avita tso/ts1 infrared ear thermometer AVITA CORPORATION k002182 12/29/2000
biomet external wrist plate BIOMET, INC. k003240 12/29/2000
cartouch CARDIONICS, INC. k002197 12/27/2000

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