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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 K100380
Device Name ALTERA NEBULIZER SYSTEM, MODEL 678G1002
Applicant
Pari Respiratory Equipment, Inc.
2943 Oak Lake Blvd.
Midlothian,  VA  23112
Applicant Contact JAMES L MCINTIRE
Correspondent
Pari Respiratory Equipment, Inc.
2943 Oak Lake Blvd.
Midlothian,  VA  23112
Correspondent Contact JAMES L MCINTIRE
Regulation Number868.5630
Classification Product Code
CAF  
Date Received02/16/2010
Decision Date 02/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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