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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Airway, Oropharyngeal, Anesthesiology
510(k) Number K913680
Device Name BERMAN INTUBATING/PHARYNGEAL AIRWAY
Applicant
Chain Plastics Operations, Inc.
2612 Frederick Ter.
Union,  NJ  07083
Applicant Contact WILLIAM JORDAN
Correspondent
Chain Plastics Operations, Inc.
2612 Frederick Ter.
Union,  NJ  07083
Correspondent Contact WILLIAM JORDAN
Regulation Number868.5110
Classification Product Code
CAE  
Date Received08/19/1991
Decision Date 10/10/1991
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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