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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K952326
Device Name PULMOMIST
Applicant
Global Medical Ent., Inc.
1590 W. 35th Pl.
Hialeah,  FL  33012
Applicant Contact SALVADOR CASTANER
Correspondent
Global Medical Ent., Inc.
1590 W. 35th Pl.
Hialeah,  FL  33012
Correspondent Contact SALVADOR CASTANER
Regulation Number868.5630
Classification Product Code
CAF  
Date Received05/18/1995
Decision Date 02/27/1996
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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