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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 K924081
Device Name LUMISONIC
Applicant
Lumiscope Co., Inc.
400 Raritan Center Pkwy.
Edison,  NJ  08837
Applicant Contact STEPHEN WHITTENBURG
Correspondent
Lumiscope Co., Inc.
400 Raritan Center Pkwy.
Edison,  NJ  08837
Correspondent Contact STEPHEN WHITTENBURG
Regulation Number868.5630
Classification Product Code
CAF  
Date Received08/13/1992
Decision Date 11/09/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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