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FDA 510(k) Application Details - K970887
Device Classification Name
Tonometer, Manual
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510(K) Number
K970887
Device Name
Tonometer, Manual
Applicant
PARADIGM MEDICAL INDUSTRIES, INC.
1772 WEST 2300 SOUTH
SALT LAKE CITY, UT 84119 US
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Contact
RICHARD DIRKSON
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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
03/11/1997
Decision Date
06/17/1997
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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