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FDA 510(k) Application Details - K181016
Device Classification Name
System, Image Management, Ophthalmic
More FDA Info for this Device
510(K) Number
K181016
Device Name
System, Image Management, Ophthalmic
Applicant
Welch Allyn, Inc.
4341 State Street Rd.
Skaneateles Falls, NY 13153 US
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Contact
Megan Pellenz
Other 510(k) Applications for this Contact
Regulation Number
892.2050
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Classification Product Code
NFJ
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More FDA Info for this Product Code
Date Received
04/17/2018
Decision Date
07/16/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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