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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 K972397
Device Name EZ SPRAY
Applicant
INTERTEX RESEARCH, INC.
2003 CASTLEROCK
P.O. BOX 90785
HOUSTON,  TX  77090
Applicant Contact JOHN BULLOCK
Correspondent
INTERTEX RESEARCH, INC.
2003 CASTLEROCK
P.O. BOX 90785
HOUSTON,  TX  77090
Correspondent Contact JOHN BULLOCK
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received06/26/1997
Decision Date 09/23/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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