FDA 510(k) Application Details - K023092

Device Classification Name Keratome, Battery-Powered

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510(K) Number K023092
Device Name Keratome, Battery-Powered
Applicant BECTON DICKINSON & CO.
1 BECTON DR.
FRANKLIN LAKES, NJ 07417-1885 US
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Contact EILEEN T SCHWEIGHARDT
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Regulation Number 886.4370

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Classification Product Code HMY
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Date Received 09/18/2002
Decision Date 10/18/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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