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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 K925061
Device Name HELLER TRANSILLUMINATING STYLETTE
Applicant
Device Resources
P.O. Box 85
Lake Bluff,  IL  60044
Applicant Contact THOMAS F LACHNER
Correspondent
Device Resources
P.O. Box 85
Lake Bluff,  IL  60044
Correspondent Contact THOMAS F LACHNER
Regulation Number876.5980
Classification Product Code
KNT  
Subsequent Product Code
FCR  
Date Received10/06/1992
Decision Date 06/27/1994
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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