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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K060399
Device Name LC SPRINT NEBULIZER
Applicant
PARI INNOVATIVE MANUFACTURERS, INC.
2943 OAKLAKE BLVD.
MIDLOTHIAN,  VA  23112
Applicant Contact MICHAEL JUDGE
Correspondent
CITECH
5200 BUTLER PIKE
PLYMOUTH MEETING,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number868.5630
Classification Product Code
CAF  
Date Received02/15/2006
Decision Date 03/02/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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