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FDA 510(k) Application Details - K034037
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K034037
Device Name
Arthroscope
Applicant
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.
555 THIRTEENTH STREET, NW
WASHINGTON, DC 20004 US
Other 510(k) Applications for this Company
Contact
JONATHAN S KAHN
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
12/29/2003
Decision Date
01/28/2004
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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