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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 K051365
Device Name COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321
Applicant
K-Jump Health Co., Ltd.
55 Norhtern Blvd.
Great Neck,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
K-Jump Health Co., Ltd.
55 Norhtern Blvd.
Great Neck,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number868.5630
Classification Product Code
CAF  
Date Received05/25/2005
Decision Date 07/22/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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