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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 K060357
Device Name TREK S NEBULIZER COMPRESSOR
Applicant
PARI INNOVATIVE MANUFACTURERS, INC.
2943 OAK LAKE 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 Received02/13/2006
Decision Date 04/05/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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