FDA 510(k) Application Details - K001144

Device Classification Name Keratome, Ac-Powered

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510(K) Number K001144
Device Name Keratome, Ac-Powered
Applicant LASERSIGHT TECHNOLOGIES, INC.
3300 UNIVERSITY BLVD.
SUITE 140
WINTER PARK, FL 32792 US
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Contact SAM MIRZA
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Regulation Number 886.4370

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Classification Product Code HNO
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Date Received 04/10/2000
Decision Date 05/05/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K001144


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