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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Connector, Tubing, Dialysate
510(k) Number K862722
Device Name TUBING CONNECTOR #10-810-60 100/PKG NON-STERILE
Applicant
Mercury Enterprises, Inc.
4645 - 145th Ave. N.
Clearwater,  FL  33520
Applicant Contact GEORGE HOWE
Correspondent
Mercury Enterprises, Inc.
4645 - 145th Ave. N.
Clearwater,  FL  33520
Correspondent Contact GEORGE HOWE
Regulation Number876.5820
Classification Product Code
FKY  
Date Received07/17/1986
Decision Date 08/11/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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