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FDA 510(k) Application Details - K963762
Device Classification Name
Topographer, Corneal, Ac-Powered
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510(K) Number
K963762
Device Name
Topographer, Corneal, Ac-Powered
Applicant
ECLIPSE VENTURES
108 SAYRE DR.
PRINCETON, NJ 08540 US
Other 510(k) Applications for this Company
Contact
RICHARD G HUNTER
Other 510(k) Applications for this Contact
Regulation Number
886.1350
More FDA Info for this Regulation Number
Classification Product Code
MMQ
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More FDA Info for this Product Code
Date Received
09/19/1996
Decision Date
12/23/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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