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FDA 510(k) Application Details - K180876
Device Classification Name
Arthroscope
More FDA Info for this Device
510(K) Number
K180876
Device Name
Arthroscope
Applicant
Providence Medical Technology, Inc.
3857 Hopyard Rd.
Suite 300
Pleasanton, CA 94588 US
Other 510(k) Applications for this Company
Contact
Edward Liou
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
04/03/2018
Decision Date
05/18/2018
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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