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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Therapeutic (Incentive)
510(k) Number K994074
Device Name TRI-BALL
Applicant
Leventon, S.A.
Poligono Can Suyer, 11
Sant Andreu De La Barca
Barcelona,  ES 08740
Applicant Contact JOAQUIM SORIANO
Correspondent
Leventon, S.A.
Poligono Can Suyer, 11
Sant Andreu De La Barca
Barcelona,  ES 08740
Correspondent Contact JOAQUIM SORIANO
Regulation Number868.5690
Classification Product Code
BWF  
Date Received12/02/1999
Decision Date 06/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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