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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing And Support, Ventilator (W Harness)
510(k) Number K823271
Device Name DISPOSABLE ADULT VO. VENTILATOR CIRCUIT
Applicant
Intec Medical, Inc.
22200 E. 40 Hwy.
Blue Springs,  MO  64015
Applicant Contact Joseph W Brown
Correspondent
Intec Medical, Inc.
22200 E. 40 Hwy.
Blue Springs,  MO  64015
Correspondent Contact Joseph W Brown
Regulation Number868.5975
Classification Product Code
BZO  
Date Received11/02/1982
Decision Date 12/22/1982
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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