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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K862098
Device Name PRISTINE/BLOOMING/PRISTINE BLOOMING CULTURE CATH
Applicant
Hall/Mccollum Laboratories, Inc.
2110 Hill St.
Charlottesville,  VA  22903
Correspondent
Hall/Mccollum Laboratories, Inc.
2110 Hill St.
Charlottesville,  VA  22903
Regulation Number876.5130
Classification Product Code
KOD  
Date Received06/02/1986
Decision Date 11/12/1986
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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