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FDA 510(k) Application Details - K221892
Device Classification Name
Rhinoanemometer (Measurement Of Nasal Decongestion)
More FDA Info for this Device
510(K) Number
K221892
Device Name
Rhinoanemometer (Measurement Of Nasal Decongestion)
Applicant
PacificMD Biotech Llc
3195 Saint Rose Pkwy, Suite 210
Henderson, NV 89052 US
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Contact
Jetmir Palushi
Other 510(k) Applications for this Contact
Regulation Number
868.1800
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Classification Product Code
BXQ
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More FDA Info for this Product Code
Date Received
06/29/2022
Decision Date
10/05/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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