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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 K002153
Device Name ULTRASONIC NEBULIZER, MODEL NE-520
Applicant
Medisana USA, Inc.
11820 Red Hibiscus Dr.
Bonita Springs,  FL  34135
Applicant Contact GUENTER GINSBERG
Correspondent
Medisana USA, Inc.
11820 Red Hibiscus Dr.
Bonita Springs,  FL  34135
Correspondent Contact GUENTER GINSBERG
Regulation Number868.5630
Classification Product Code
CAF  
Date Received07/17/2000
Decision Date 03/13/2001
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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