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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nebulizer, medicinal, non-ventilatory (atomizer)
510(k) Number K842988
Device Name VMT GENTLE-HALER
Applicant
VORTRAN MEDICAL TECHNOLOGY 1, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
VORTRAN MEDICAL TECHNOLOGY 1, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received07/30/1984
Decision Date 08/07/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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