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FDA 510(k) Application Details - K000279
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K000279
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 BREN RD., WEST
MINNETONKA, MN 55343 US
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Contact
SYLVIA L GUBBE
Other 510(k) Applications for this Contact
Regulation Number
888.3040
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Classification Product Code
MBI
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More FDA Info for this Product Code
Date Received
01/31/2000
Decision Date
03/01/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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