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FDA 510(k) Application Details - K081004
Device Classification Name
Colonoscope And Accessories, Flexible/Rigid
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510(K) Number
K081004
Device Name
Colonoscope And Accessories, Flexible/Rigid
Applicant
STRYKER GI
1420 LAKESIDE PARKWAY, #110
FLOWER MOUND, TX 75028 US
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Contact
TIFFANI ROGERS
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Regulation Number
876.1500
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Classification Product Code
FDF
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More FDA Info for this Product Code
Date Received
04/08/2008
Decision Date
05/02/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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