FDA 510(k) Application Details - K020079

Device Classification Name Keratome, Ac-Powered

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510(K) Number K020079
Device Name Keratome, Ac-Powered
Applicant BLADE WORKS, INC.
1816 TOWHEE ST.
SAN MARCOS, CA 92069 US
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Contact MARK MOYER
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Regulation Number 886.4370

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Classification Product Code HNO
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Date Received 01/10/2002
Decision Date 04/19/2002
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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