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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K022465
Device Name MODIFICATION TO NASAL-AIRE
Applicant
Innomed Technologies
506 Garden St.
Greensburg,  PA  15601
Applicant Contact MARGE WALLS-WALKER
Correspondent
Innomed Technologies
506 Garden St.
Greensburg,  PA  15601
Correspondent Contact MARGE WALLS-WALKER
Regulation Number868.5905
Classification Product Code
BZD  
Date Received07/26/2002
Decision Date 03/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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