FDA 510(k) Application Details - K013762

Device Classification Name Lens, Contact (Other Material) - Daily

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510(K) Number K013762
Device Name Lens, Contact (Other Material) - Daily
Applicant BAUSCH & LOMB INCORPORATED
1400 N. GOODMAN ST.
PO BOX 30450
ROCHESTER, NY 14603-0450 US
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Contact DEBRA L.B. KETCHUM
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Regulation Number 886.5916

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Classification Product Code HQD
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Date Received 11/13/2001
Decision Date 04/03/2002
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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