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FDA 510(k) Application Details - K202036
Device Classification Name
Lens, Contact, (Disposable)
More FDA Info for this Device
510(K) Number
K202036
Device Name
Lens, Contact, (Disposable)
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
886.5925
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
07/23/2020
Decision Date
08/21/2020
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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