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FDA 510(k) Application Details - K023245
Device Classification Name
Tonometer, Analyzer, Ocular Blood Flow
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510(K) Number
K023245
Device Name
Tonometer, Analyzer, Ocular Blood Flow
Applicant
PARADIGM MEDICAL INDUSTRIES, INC.
2355 SOUTH 1070 WEST
SALT LAKE CITY, UT 84119 US
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Contact
DAVID M SILVER
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Regulation Number
886.1930
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Classification Product Code
NJJ
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More FDA Info for this Product Code
Date Received
09/30/2002
Decision Date
10/21/2002
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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