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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K082322
Device Name AIR ASSISTED SPRAYER, MODELS: AIRSPRAYUS01 AND AIRSPRAYUS
Applicant
Covidien
101a First Ave.
Waltham,  MA  02451
Applicant Contact VIRGINIA VETTER
Correspondent
Covidien
101a First Ave.
Waltham,  MA  02451
Correspondent Contact VIRGINIA VETTER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received08/13/2008
Decision Date 11/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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