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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 And Tube Cuff
510(k) Number K885129
Device Name MODIFIED FOME-CUF SILICONE TRACHEOSTOMY TUBE
Applicant
Bivona Medical Technologies
5700 W. 23rd.Ave.
Gary,  IN  46406
Applicant Contact M KAUFMAN
Correspondent
Bivona Medical Technologies
5700 W. 23rd.Ave.
Gary,  IN  46406
Correspondent Contact M KAUFMAN
Regulation Number868.5800
Classification Product Code
JOH  
Date Received12/12/1988
Decision Date 02/27/1989
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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