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FDA 510(k) Application Details - K011456
Device Classification Name
Products, Contact Lens Care, Rigid Gas Permeable
More FDA Info for this Device
510(K) Number
K011456
Device Name
Products, Contact Lens Care, Rigid Gas Permeable
Applicant
SAUFLON PHARMACEUTICALS, LTD.
203 N. WABASH AVE.
SUITE 1200
CHICAGO, IL 60601 US
Other 510(k) Applications for this Company
Contact
JOHN M SZABOCSIK
Other 510(k) Applications for this Contact
Regulation Number
886.5918
More FDA Info for this Regulation Number
Classification Product Code
MRC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/11/2001
Decision Date
07/17/2001
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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