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FDA 510(k) Application Details - K973875
Device Classification Name
Irrigator, Powered Nasal
More FDA Info for this Device
510(K) Number
K973875
Device Name
Irrigator, Powered Nasal
Applicant
RESPIRONICS, INC.
1001 MURRY RIDGE LN.
MURRYSVILLE, PA 15668 US
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Contact
FRANCIS X DOBSCHA
Other 510(k) Applications for this Contact
Regulation Number
874.5550
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Classification Product Code
KMA
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More FDA Info for this Product Code
Date Received
10/10/1997
Decision Date
01/26/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
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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