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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 K930949
Device Name VOYAGE
Applicant
MADA MEDICAL PRODUCTS, INC.
60 COMMERCE RD.
CARLSTADT,  NJ  07072
Applicant Contact JEFFREY ADAM
Correspondent
MADA MEDICAL PRODUCTS, INC.
60 COMMERCE RD.
CARLSTADT,  NJ  07072
Correspondent Contact JEFFREY 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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