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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Airway, Nasopharyngeal
510(k) Number K921353
Device Name NASOPHARYNGEAL AIRWAY
Applicant
Coast Medical Corp.
1060 N. Batavia
Unit H
Orange,  CA  92667
Applicant Contact DOYGLAS R MONGEON
Correspondent
Coast Medical Corp.
1060 N. Batavia
Unit H
Orange,  CA  92667
Correspondent Contact DOYGLAS R MONGEON
Regulation Number868.5100
Classification Product Code
BTQ  
Date Received03/19/1992
Decision Date 06/11/1992
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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