FDA 510(k) Application Details - K011718

Device Classification Name Lens, Contact, (Disposable)

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510(K) Number K011718
Device Name Lens, Contact, (Disposable)
Applicant BAUSCH & LOMB, INC.
1400 NORTH GOODMAN ST.
P.O.BOX 450
ROCHESTER, NY 14692 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 06/04/2001
Decision Date 07/25/2001
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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