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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, tracheostomy (w/wo connector)
510(k) Number K884015
Device Name PREMIER DECANNULATION STOPPER
Applicant
PREMIER DENTAL
ROMANO DR.
P.O. BOX 111
NORRISTOWN,  PA  19404
Applicant Contact WILLIAM J FREZEL
Correspondent
PREMIER DENTAL
ROMANO DR.
P.O. BOX 111
NORRISTOWN,  PA  19404
Correspondent Contact WILLIAM J FREZEL
Regulation Number868.5800
Classification Product Code
BTO  
Date Received09/22/1988
Decision Date 11/03/1988
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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