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FDA 510(k) Application Details - K963434
Device Classification Name
Pump, Infusion, Ophthalmic
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510(K) Number
K963434
Device Name
Pump, Infusion, Ophthalmic
Applicant
ESCALON TREK MEDICAL
822 SWAN DR.
MUKWONAGO, WI 53149 US
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Contact
RONALD L HUENEKE
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Regulation Number
880.5725
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Classification Product Code
MRH
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More FDA Info for this Product Code
Date Received
08/30/1996
Decision Date
11/25/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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