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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 K823291
Device Name COMMUNITRACH TUBE
Applicant
Implant Technology, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Implant Technology, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.5800
Classification Product Code
BTO  
Date Received11/05/1982
Decision Date 01/08/1983
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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