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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 LANE PLACE
CAZENOVIA,  NY  13035 -0642
Applicant Contact THOMAS R GUNERMAN
Correspondent
INTERSURGICAL, INC.
P.O. BOX 642
CARRIAGE LANE PLACE
CAZENOVIA,  NY  13035 -0642
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
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