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FDA 510(k) Application Details - K992998
Device Classification Name
Tonometer, Manual
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510(K) Number
K992998
Device Name
Tonometer, Manual
Applicant
AUTOMATED OPHTHALMICS, INC.
8253 GLEMAR RD.
ELLICOTT, MD 21043 US
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Contact
NORMAN BICKMAN
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Regulation Number
886.1930
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Classification Product Code
HKY
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More FDA Info for this Product Code
Date Received
09/07/1999
Decision Date
01/10/2000
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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