FDA 510(k) Application Details - K080755

Device Classification Name Lens, Contact, (Disposable)

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510(K) Number K080755
Device Name Lens, Contact, (Disposable)
Applicant BAUSCH & LOMB, INC.
1400 NORTH GOODMAN ST.
ROCHESTER, NY 14609-3547 US
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Contact DEBRA KETCHUM
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Regulation Number 886.5925

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Classification Product Code MVN
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Date Received 03/17/2008
Decision Date 06/10/2008
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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