FDA 510(k) Application Details - K012873

Device Classification Name Biomicroscope, Slit-Lamp, Ac-Powered

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510(K) Number K012873
Device Name Biomicroscope, Slit-Lamp, Ac-Powered
Applicant BAUSCH & LOMB, INC.
9342 JERONIMO RD.
IRVINE, CA 92618 US
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Contact PENNI L PANNELL
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Regulation Number 886.1850

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Classification Product Code HJO
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Date Received 08/27/2001
Decision Date 11/19/2001
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



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