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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 K851334
Device Name AIRLIFE ELECTRONIC INCENTIVE SPIROMETER
Applicant
American Pharmaseal Div. Ahsc
1015 Grandview
P.O. Box 1300
Glendale,  CA  91209
Applicant Contact LAWRNECE W GETLIN
Correspondent
American Pharmaseal Div. Ahsc
1015 Grandview
P.O. Box 1300
Glendale,  CA  91209
Correspondent Contact LAWRNECE W GETLIN
Regulation Number868.5690
Classification Product Code
BWF  
Date Received04/01/1985
Decision Date 08/06/1985
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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