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FDA 510(k) Application Details - K160677
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K160677
Device Name
Powered Laser Surgical Instrument
Applicant
MERIDIAN AG
BIERIGUTSTRASSE 7
THUN CH-3608 CH
Other 510(k) Applications for this Company
Contact
FRANZISKA GOTSCHI
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
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More FDA Info for this Product Code
Date Received
03/10/2016
Decision Date
05/19/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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