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FDA 510(k) Application Details - K962989
Device Classification Name
Burr, Corneal, Battery-Powered
More FDA Info for this Device
510(K) Number
K962989
Device Name
Burr, Corneal, Battery-Powered
Applicant
S. PERCY AMOILS
333 WEST WACKER DR.
SUITE 2600
CHICAGO, IL 60606 US
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Contact
RICHARD O WOOD, ESQ.
Other 510(k) Applications for this Contact
Regulation Number
886.4070
More FDA Info for this Regulation Number
Classification Product Code
HOG
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More FDA Info for this Product Code
Date Received
08/01/1996
Decision Date
01/09/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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