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FDA 510(k) Application Details - K990064
Device Classification Name
Apparatus, Cautery, Radiofrequency, Ac-Powered
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510(K) Number
K990064
Device Name
Apparatus, Cautery, Radiofrequency, Ac-Powered
Applicant
OPHTHALMIC TECHNOLOGIES, INC.
37 KODIAK CRESCENT,
UNIT 12
DOWNSVIEW, ONTARIO MEJ 3E5 CA
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GEORGE MYERS
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Regulation Number
886.4100
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Classification Product Code
HQR
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More FDA Info for this Product Code
Date Received
01/08/1999
Decision Date
04/04/1999
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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