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FDA 510(k) Application Details - K210536
Device Classification Name
Lavage, Jet
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510(K) Number
K210536
Device Name
Lavage, Jet
Applicant
Irrimax Corporation
1665 Lakes Parkway, Suite 102
Lawrenceville, GA 30043 US
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Contact
Christy Coleman
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Regulation Number
880.5475
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Classification Product Code
FQH
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Date Received
02/24/2021
Decision Date
05/28/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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