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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 K972778
Device Name DEY VIAL SODIUM CHLORIDE 3%
Applicant
DEY LABORATORIES, INC.
2751 NAPA VALLEY CORPORATE
DRIVE
NAPA,  CA  94558
Applicant Contact ALLAN S KAPLAN
Correspondent
DEY LABORATORIES, INC.
2751 NAPA VALLEY CORPORATE
DRIVE
NAPA,  CA  94558
Correspondent Contact ALLAN S KAPLAN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received07/25/1997
Decision Date 10/08/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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