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FDA 510(k) Application Details - K974243
Device Classification Name
Keratome, Battery-Powered
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510(K) Number
K974243
Device Name
Keratome, Battery-Powered
Applicant
INSIGHT TECHNOLOGIES INSTRUMENTS, LLC.
16 HIGGINS DR.
MILFORD, CT 06460 US
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Contact
CHARLES VASSALLO
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Regulation Number
886.4370
More FDA Info for this Regulation Number
Classification Product Code
HMY
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More FDA Info for this Product Code
Date Received
11/12/1997
Decision Date
01/20/1998
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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