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FDA 510(k) Application Details - K962135
Device Classification Name
Unit, Cautery, Thermal, Ac-Powered
More FDA Info for this Device
510(K) Number
K962135
Device Name
Unit, Cautery, Thermal, Ac-Powered
Applicant
DUTCH OPHTHALMIC USA, INC.
ONE LITTLE RIVER RD.
P.O. BOX 968
KINGSTON, NH 03848 US
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Contact
MARK W FURLONG
Other 510(k) Applications for this Contact
Regulation Number
886.4115
More FDA Info for this Regulation Number
Classification Product Code
HQO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/03/1996
Decision Date
08/29/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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