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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Compressor, Air, Portable
510(k) Number K844956
Device Name AVA-MIST PORTABLE AIR COMPRESSOR
Applicant
Avatron, Inc.
2970 Bay Vista Ct.
P.O. Box 429
Benicia,  CA  94510
Applicant Contact RUSSELL CLARK
Correspondent
Avatron, Inc.
2970 Bay Vista Ct.
P.O. Box 429
Benicia,  CA  94510
Correspondent Contact RUSSELL CLARK
Regulation Number868.6250
Classification Product Code
BTI  
Date Received12/21/1984
Decision Date 02/14/1985
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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