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FDA 510(k) Application Details - K162597
Device Classification Name
Accessories, Soft Lens Products
More FDA Info for this Device
510(K) Number
K162597
Device Name
Accessories, Soft Lens Products
Applicant
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099 US
Other 510(k) Applications for this Company
Contact
Sherri Lakota
Other 510(k) Applications for this Contact
Regulation Number
886.5928
More FDA Info for this Regulation Number
Classification Product Code
LPN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/19/2016
Decision Date
10/19/2016
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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