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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 K933961
Device Name MARSAM MODEL 2000 NEBULIZER
Applicant
Marsam Pharmaceuticals, Inc.
Olney Ave. P.O. Box 1022
Cherry Hill,  NJ  08034
Applicant Contact JUDITH U ARNOFF
Correspondent
Marsam Pharmaceuticals, Inc.
Olney Ave. P.O. Box 1022
Cherry Hill,  NJ  08034
Correspondent Contact JUDITH U ARNOFF
Regulation Number868.5630
Classification Product Code
CAF  
Date Received08/13/1993
Decision Date 09/19/1995
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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