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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 K883829
Device Name TURBO AIR COMPRESSOR 8000
Applicant
Necon Medical, Inc.
P.O. Box G
Vernon Industrial Place
Vernon,  CT  06066
Applicant Contact CHRIS J BRIELMANN
Correspondent
Necon Medical, Inc.
P.O. Box G
Vernon Industrial Place
Vernon,  CT  06066
Correspondent Contact CHRIS J BRIELMANN
Regulation Number868.6250
Classification Product Code
BTI  
Date Received09/09/1988
Decision Date 03/23/1989
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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