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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 K911422
Device Name DRUG NEBULIZERS
Applicant
Intersurgical, Inc.
P.O. Box 642
Carriage Ln. Pl.
Cazenovia,  NY  13035
Applicant Contact THOMAS R GUNERMAN
Correspondent
Intersurgical, Inc.
P.O. Box 642
Carriage Ln. Pl.
Cazenovia,  NY  13035
Correspondent Contact THOMAS R GUNERMAN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received02/05/1991
Decision Date 10/23/1991
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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