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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameGLUCOWATCH G2 BIOGRAPHER
Classification Nameglucose oxidase, glucose
Generic Nameinstrument, glucose, noninvasive technology\
Regulation Number862.1345
ApplicantCYGNUS, INC.
PMA NumberP990026
Supplement NumberS016
Date Received12/13/2002
Decision Date12/31/2002
Product Code
CGA[ Registered Establishments with CGA ]
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the pcba wash process in the pcba assembly sequence to increase the efficiency of the process and to reduce cost.
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