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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 K872486
Device Name LARKEL DEVICE W/ATTACHMENTS A-H
Applicant
Seidel Medizin GmbH
3601 Wisconsin Ave., NW #409
Washington,  DC  20016
Applicant Contact DANIEL J DZUREK
Correspondent
Seidel Medizin GmbH
3601 Wisconsin Ave., NW #409
Washington,  DC  20016
Correspondent Contact DANIEL J DZUREK
Regulation Number868.5800
Classification Product Code
BTO  
Date Received06/23/1987
Decision Date 09/16/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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