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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 K982128
Device Name SHIKANI-FRENCH SPEAKING VALVE
Applicant
PILLING WECK SURGICAL
420 DELAWARE DR.
FORT WASHINGTON,  PA  19034
Applicant Contact ELIZABETH LAZARO
Correspondent
PILLING WECK SURGICAL
420 DELAWARE DR.
FORT WASHINGTON,  PA  19034
Correspondent Contact ELIZABETH LAZARO
Regulation Number868.5800
Classification Product Code
JOH  
Date Received06/17/1998
Decision Date 10/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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