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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Emergency Airway
510(k) Number K790650
Device Name WEISS EMERGENCY AIRWAY SYSTEM
Applicant
Intl. Medical Devices , Ltd.
530 Seco Rd.
Monroeville,  PA  15146
Correspondent
Intl. Medical Devices , Ltd.
530 Seco Rd.
Monroeville,  PA  15146
Regulation Number868.5090
Classification Product Code
BWC  
Date Received04/03/1979
Decision Date 06/27/1979
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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