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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 K880411
Device Name DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE
Applicant
DEY LABORATORIES, INC.
1011 DETROIT AVE.
CONCORD,  CA  94518
Applicant Contact RAFF, PHD
Correspondent
DEY LABORATORIES, INC.
1011 DETROIT AVE.
CONCORD,  CA  94518
Correspondent Contact RAFF, PHD
Regulation Number868.5630
Classification Product Code
CAF  
Date Received02/01/1988
Decision Date 02/29/1988
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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