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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 K893390
Device Name MODIFIED PRISTINE CULTURE CATHETER
Applicant
Hml Medical, Inc.
11 Marconi St.
Irvine,  CA  92718
Applicant Contact ERIC M LOVGREN
Correspondent
Hml Medical, Inc.
11 Marconi St.
Irvine,  CA  92718
Correspondent Contact ERIC M LOVGREN
Regulation Number876.5130
Classification Product Code
KOD  
Date Received05/01/1989
Decision Date 09/07/1989
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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