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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stylet, tracheal tube
510(k) Number K914965
Device Name DISPOSABLE STYLETTE WITH END CAP
Applicant
PIVIC PROMEDCO
2328 MAPLEWOOD ST.
ORANGE,  CA  92665
Applicant Contact DOUG MONGEON
Correspondent
PIVIC PROMEDCO
2328 MAPLEWOOD ST.
ORANGE,  CA  92665
Correspondent Contact DOUG MONGEON
Regulation Number868.5790
Classification Product Code
BSR  
Date Received11/05/1991
Decision Date 05/27/1992
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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