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FDA 510(k) Application Details - K992941
Device Classification Name
Dislodger, Stone, Biliary
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510(K) Number
K992941
Device Name
Dislodger, Stone, Biliary
Applicant
VASCUTECH, INC.
164 MIDDLESEX TURNPIKE
BURLINGTON, MA 01803 US
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Contact
TRENT G KAMKE
Other 510(k) Applications for this Contact
Regulation Number
876.5010
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Classification Product Code
LQR
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More FDA Info for this Product Code
Date Received
08/31/1999
Decision Date
01/12/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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