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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 K844591
Device Name MIST-EASE NEBULIZER
Applicant
General Physiotherapy, Inc.
1520 Washington Ave.
St. Louis,  MO  63103
Applicant Contact THOMAS P MUCHISKY
Correspondent
General Physiotherapy, Inc.
1520 Washington Ave.
St. Louis,  MO  63103
Correspondent Contact THOMAS P MUCHISKY
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received11/26/1984
Decision Date 12/13/1984
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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