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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 K942384
Device Name ENDURANCE R3000
Applicant
Essential Medical Supply, Inc.
6937-A Stapoint Ct.
Winter Park,  FL  32792
Applicant Contact CAROL A HOEPNER
Correspondent
Essential Medical Supply, Inc.
6937-A Stapoint Ct.
Winter Park,  FL  32792
Correspondent Contact CAROL A HOEPNER
Regulation Number868.5630
Classification Product Code
CAF  
Date Received05/19/1994
Decision Date 12/19/1994
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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