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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Catheter
510(k) Number K864115
Device Name TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR SU
Applicant
Cathaid, Inc.
P.O. Box 161455
Miami,  FL  33116
Applicant Contact HOWARD F SCOTT
Correspondent
Cathaid, Inc.
P.O. Box 161455
Miami,  FL  33116
Correspondent Contact HOWARD F SCOTT
Regulation Number878.4200
Classification Product Code
KGZ  
Date Received10/10/1986
Decision Date 11/07/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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