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FDA 510(k) Application Details - K173538
Device Classification Name
Case, Contact Lens
More FDA Info for this Device
510(K) Number
K173538
Device Name
Case, Contact Lens
Applicant
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099 US
Other 510(k) Applications for this Company
Contact
Katryna Warren
Other 510(k) Applications for this Contact
Regulation Number
886.5928
More FDA Info for this Regulation Number
Classification Product Code
LRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/15/2017
Decision Date
12/04/2017
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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