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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 K851254
Device Name MICRO-INHALER MODEL TV-7000 & TV-8000
Applicant
Bioclimatic, Inc.
520 Fellowship Rd.
Mt. Laurel,  NJ  08054
Applicant Contact ZITIN
Correspondent
Bioclimatic, Inc.
520 Fellowship Rd.
Mt. Laurel,  NJ  08054
Correspondent Contact ZITIN
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received03/28/1985
Decision Date 06/18/1985
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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