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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 K874450
Device Name SCHACHNER-OVIL RAPITRAC PERCUTAN. TRACHEOSTOMY KIT
Applicant
SURGITECH C/O COLLIER, SHANNON, RILL & SCOTT
1055 THOMAS JEFFERSON ST. N.W.
WASHINGTON,  DC  20007
Applicant Contact RICHARD S SILVERMAN
Correspondent
SURGITECH C/O COLLIER, SHANNON, RILL & SCOTT
1055 THOMAS JEFFERSON ST. N.W.
WASHINGTON,  DC  20007
Correspondent Contact RICHARD S SILVERMAN
Regulation Number868.5800
Classification Product Code
BTO  
Date Received10/29/1987
Decision Date 02/29/1988
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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