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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name heater, breathing system w/wo controller (not humidifier or nebulizer
510(k) Number K860941
Device Name DISPOSABLE HEATED WIRE LOOPS 48 AND 72
Applicant
INTEC MEDICAL, INC.
22200 E. 40 HWY
BLUE SPRINGS,  MO  64015
Applicant Contact J. W BROWN
Correspondent
INTEC MEDICAL, INC.
22200 E. 40 HWY
BLUE SPRINGS,  MO  64015
Correspondent Contact J. W BROWN
Regulation Number868.5270
Classification Product Code
BZE  
Date Received03/12/1986
Decision Date 04/02/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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