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FDA 510(k) Application Details - K061157
Device Classification Name
Lens, Contact, (Disposable)
More FDA Info for this Device
510(K) Number
K061157
Device Name
Lens, Contact, (Disposable)
Applicant
BAUSCH & LOMB
1400 NORTH GOODMAN ST.
ROCHESTER, NY 14609-3547 US
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Contact
DEBRA KETCHUM
Other 510(k) Applications for this Contact
Regulation Number
886.5925
More FDA Info for this Regulation Number
Classification Product Code
MVN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/26/2006
Decision Date
06/22/2006
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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