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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 K953559
Device Name LARKEL DEVICE WITH ATTACHMENTS A-H(MODIFICATION)
Applicant
SEIDEL MEDIZIN GMBH
16 STOCKDORFER WEG
BUCHENDORF,  DE D-82131
Applicant Contact MARTHA STRASSER
Correspondent
SEIDEL MEDIZIN GMBH
16 STOCKDORFER WEG
BUCHENDORF,  DE D-82131
Correspondent Contact MARTHA STRASSER
Regulation Number868.5800
Classification Product Code
BTO  
Date Received06/20/1995
Decision Date 05/16/1996
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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