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FDA 510(k) Application Details - K990443
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K990443
Device Name
Arthroscope
Applicant
W.O.M. WORLD OF MEDICINE, GMBH
194 BRANCH ST.
MANSFIELD, MA 02048 US
Other 510(k) Applications for this Company
Contact
MICHAEL MCGRAIL
Other 510(k) Applications for this Contact
Regulation Number
888.1100
More FDA Info for this Regulation Number
Classification Product Code
HRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/11/1999
Decision Date
02/26/1999
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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