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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 K882953
Device Name HYDRAMED BY LECHLER
Applicant
LECHLER, INC.
445 KAUTZ RD.
ST. CHARLES,  IL  60174
Applicant Contact PETER WELANDER
Correspondent
LECHLER, INC.
445 KAUTZ RD.
ST. CHARLES,  IL  60174
Correspondent Contact PETER WELANDER
Regulation Number868.5630
Classification Product Code
CAF  
Date Received07/14/1988
Decision Date 10/12/1988
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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