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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
510(k) Number K895115
Device Name FRANK INHALER THERMAL S
Applicant
Buttner-Frank GmbH
8520 Erlangen-Tennenlohe
Am Wolfsmantel 9/Gewerbegabiet
Postfach 1266,  DE
Applicant Contact BLANK
Correspondent
Buttner-Frank GmbH
8520 Erlangen-Tennenlohe
Am Wolfsmantel 9/Gewerbegabiet
Postfach 1266,  DE
Correspondent Contact BLANK
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received08/15/1989
Decision Date 05/18/1990
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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