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FDA 510(k) Application Details - K231023
Device Classification Name
Lavage, Jet
More FDA Info for this Device
510(K) Number
K231023
Device Name
Lavage, Jet
Applicant
Erbe Elektromedizin GmbH
Waldhoernlestrasse 17
Tuebingen 72072 DE
Other 510(k) Applications for this Company
Contact
Matthias Kollek
Other 510(k) Applications for this Contact
Regulation Number
880.5475
More FDA Info for this Regulation Number
Classification Product Code
FQH
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More FDA Info for this Product Code
Date Received
04/11/2023
Decision Date
06/15/2023
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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