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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 K923698
Device Name BETAMIST 2
Applicant
Rantran, Inc.
2624 Beaver Glen Dr.
Ashland,  VA  23005
Applicant Contact ED RANSOM
Correspondent
Rantran, Inc.
2624 Beaver Glen Dr.
Ashland,  VA  23005
Correspondent Contact ED RANSOM
Regulation Number868.5630
Classification Product Code
CAF  
Date Received07/24/1992
Decision Date 02/18/1993
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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