FDA 510(k) Application Details - K962135

Device Classification Name Unit, Cautery, Thermal, Ac-Powered

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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
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Regulation Number 886.4115

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Classification Product Code HQO
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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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