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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 and tube cuff
510(k) Number K894050
Device Name MODIFIED DECANNULATION STOPPER
Applicant
PREMIER MEDICAL
10090 SANDMEYER LN.
PHILADELPHIA,  PA  19116 -3502
Applicant Contact WILLIAM J FREZEL
Correspondent
PREMIER MEDICAL
10090 SANDMEYER LN.
PHILADELPHIA,  PA  19116 -3502
Correspondent Contact WILLIAM J FREZEL
Regulation Number868.5800
Classification Product Code
JOH  
Date Received06/07/1989
Decision Date 08/01/1989
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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