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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K864218
FOIA Releasable 510(k) K864218
Device Name PROCON
Applicant
Healthcare Management Systems
3160 N. Trackee Ln. #22
Sparks,  NV  89431
Applicant Contact MICHAEL E FISHER
Correspondent
Healthcare Management Systems
3160 N. Trackee Ln. #22
Sparks,  NV  89431
Correspondent Contact MICHAEL E FISHER
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/28/1986
Decision Date 01/12/1987
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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