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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Support, Breathing Tube
510(k) Number K850924
Device Name JEE FRAME (VENTILATOR CIRCUIT SUPPORT)
Applicant
Vulcan Laboratories, Inc.
8038 Rugby Ave.
Birmingham,  AL  35206
Applicant Contact JOE EMRICO
Correspondent
Vulcan Laboratories, Inc.
8038 Rugby Ave.
Birmingham,  AL  35206
Correspondent Contact JOE EMRICO
Regulation Number868.5280
Classification Product Code
JAY  
Date Received03/05/1985
Decision Date 07/19/1985
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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