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FDA 510(k) Application Details - K161981
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K161981
Device Name
Powered Laser Surgical Instrument
Applicant
AMA NETWORK INC
3600 WILSHIRE BLVD #1016
LOS ANGELES, CA 90010 US
Other 510(k) Applications for this Company
Contact
YONG BAIK KIMM
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/19/2016
Decision Date
10/14/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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