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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 K871904
Device Name TOTAL LUNG EXERCISER (TLE)
Applicant
MBA Healthcare Products, Inc.
519 E. Genesee St.
P.O. Box 617
Fayetteville,  NY  13066
Applicant Contact THOMAS FALCONE
Correspondent
MBA Healthcare Products, Inc.
519 E. Genesee St.
P.O. Box 617
Fayetteville,  NY  13066
Correspondent Contact THOMAS FALCONE
Regulation Number868.5690
Classification Product Code
BWF  
Date Received05/15/1987
Decision Date 07/08/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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