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FDA 510(k) Application Details - K980734
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K980734
Device Name
Arthroscope
Applicant
MYELOTEC, INC.
4000 NORTHFIELD WAY, SUITE 900
ROSWELL, GA 30076 US
Other 510(k) Applications for this Company
Contact
THOMAS A DUNKLE
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
02/25/1998
Decision Date
08/11/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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