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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 K930947
Device Name PROMENADE
Applicant
MADA MEDICAL PRODUCTS, INC.
60 COMMERCE RD.
CARLSTADT,  NJ  07072
Applicant Contact JEFFREY W ADAM
Correspondent
MADA MEDICAL PRODUCTS, INC.
60 COMMERCE RD.
CARLSTADT,  NJ  07072
Correspondent Contact JEFFREY W ADAM
Regulation Number868.5630
Classification Product Code
CAF  
Date Received02/23/1993
Decision Date 06/01/1993
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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