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FDA 510(k) Application Details - K011718
Device Classification Name
Lens, Contact, (Disposable)
More FDA Info for this Device
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
Other 510(k) Applications for this Company
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
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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