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FDA 510(k) Application Details - K954834
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K954834
Device Name
Powered Laser Surgical Instrument
Applicant
CERAMOPTEC, INC.
515 SHAKER RD.
EAST LONGMEADOW, MA 01028 US
Other 510(k) Applications for this Company
Contact
CAROL J MORELLO
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
10/20/1995
Decision Date
01/17/1996
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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