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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 K130379
Device Name ROLLINS 7 OXYGEN MASK
Applicant
ROLLINS MEDICAL SOLUTIONS, INC.
1468 HARWELL AVE.
CROFTON,  MD  21114
Applicant Contact E. J SMITH
Correspondent
ROLLINS MEDICAL SOLUTIONS, INC.
1468 HARWELL AVE.
CROFTON,  MD  21114
Correspondent Contact E. J SMITH
Regulation Number868.5630
Classification Product Code
CAF  
Date Received02/14/2013
Decision Date 10/09/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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