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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleaner, Air, Medical Recirculating
510(k) Number K981841
Device Name BREATHE EASY, MODELS AD AND CD
Applicant
RESPIRAID LTD.
117 AHUZAH ST.
RA'ANANNA,  IL 43373
Applicant Contact SHOSHANA FRIEDMAN
Correspondent
RESPIRAID LTD.
117 AHUZAH ST.
RA'ANANNA,  IL 43373
Correspondent Contact SHOSHANA FRIEDMAN
Regulation Number880.5045
Classification Product Code
FRF  
Date Received05/26/1998
Decision Date 10/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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