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FDA 510(k) Application Details - K981907
Device Classification Name
Pump, Infusion, Ophthalmic
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510(K) Number
K981907
Device Name
Pump, Infusion, Ophthalmic
Applicant
PEREGRINE SURGICAL LTD.
4050 D SKYRON DR.
DOYLESTOWN, PA 18901 US
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Contact
TODD RICHMOND
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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
06/01/1998
Decision Date
08/04/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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