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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K926498
Device Name ENDOGRIP
Applicant
Biomedix, Inc.
23 Soutlh Main St.
P.O. Box 231
Spencer,  IN  47460
Applicant Contact DUNCAN GILMORE
Correspondent
Biomedix, Inc.
23 Soutlh Main St.
P.O. Box 231
Spencer,  IN  47460
Correspondent Contact DUNCAN GILMORE
Regulation Number868.5730
Classification Product Code
BTR  
Date Received12/29/1992
Decision Date 04/07/1993
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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