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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
510(k) Number K860800
Device Name ROSENTHAL-FRENCH NEBULIZATION DOSIMETER
Applicant
Laboratory For Applied Immunology, Inc.
8318 Arlington Blvd.,
Suite 306
Fairfax,  VA  22031
Applicant Contact RICHARD R ROSENTHAL
Correspondent
Laboratory For Applied Immunology, Inc.
8318 Arlington Blvd.,
Suite 306
Fairfax,  VA  22031
Correspondent Contact RICHARD R ROSENTHAL
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received03/04/1986
Decision Date 03/27/1986
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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