FDA 510(k) Application Details - K202036

Device Classification Name Lens, Contact, (Disposable)

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510(K) Number K202036
Device Name Lens, Contact, (Disposable)
Applicant Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134-2099 US
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Contact Sherri Lakota
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Regulation Number 886.5925

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Classification Product Code MVN
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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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