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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Irrigator, Powered Nasal
510(k) Number K963550
Device Name RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM
Applicant
Respironics, Inc.
1001 Murry Ridge Ln.
Murrysville,  PA  15668
Applicant Contact FRAMCIS X DOBSCHA
Correspondent
Respironics, Inc.
1001 Murry Ridge Ln.
Murrysville,  PA  15668
Correspondent Contact FRAMCIS X DOBSCHA
Regulation Number874.5550
Classification Product Code
KMA  
Date Received09/05/1996
Decision Date 11/01/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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