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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 K062158
Device Name LC SPRINT STAR
Applicant
Pari Innovative Manufacturers, Inc.
2943 Oak Lake Blvd.
Midlothian,  VA  23112
Applicant Contact MIKE JUDGE
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact NEIL E DEVINE
Regulation Number868.5630
Classification Product Code
CAF  
Date Received07/28/2006
Decision Date 08/28/2006
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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