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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Nasal, Oxygen
510(k) Number K860261
Device Name CANNULA BAND
Applicant
T. G. & E. Medical
125 E. Idaho, Suite 105
Boise,  ID  83712
Applicant Contact TALBOY, JR
Correspondent
T. G. & E. Medical
125 E. Idaho, Suite 105
Boise,  ID  83712
Correspondent Contact TALBOY, JR
Regulation Number868.5340
Classification Product Code
CAT  
Date Received01/24/1986
Decision Date 02/18/1986
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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