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FDA 510(k) Application Details - K010636
Device Classification Name
Lens, Contact, (Disposable)
More FDA Info for this Device
510(K) Number
K010636
Device Name
Lens, Contact, (Disposable)
Applicant
CIBA VISION CORPORATION
11460 JOHNS CREEK PKWY.
DULUTH, GA 30097 US
Other 510(k) Applications for this Company
Contact
ALICIA M PLESNARSKI
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
03/05/2001
Decision Date
03/23/2001
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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