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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Connector, Airway (Extension)
510(k) Number K810621
Device Name DISPOSABLE 22MM. FLEXIBLE ADAPTOR
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 Number868.5810
Classification Product Code
BZA  
Date Received03/09/1981
Decision Date 04/17/1981
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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