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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Intravascular Catheter Securement
510(k) Number K941850
Device Name IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE
Applicant
TNT MOBORG INTL. LTD.
693 SENECA ST.
BUFFALO,  NY  14210
Applicant Contact DENNIS R TOLLINI
Correspondent
TNT MOBORG INTL. LTD.
693 SENECA ST.
BUFFALO,  NY  14210
Correspondent Contact DENNIS R TOLLINI
Regulation Number880.5210
Classification Product Code
KMK  
Date Received04/14/1994
Decision Date 07/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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