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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 K860052
Device Name QWIK-CALL
Applicant
Emde Corp.
The Liberty Center
350 S. Center St., Suite 340
Reno,  NV  89501
Applicant Contact MICHAEL H SNYDER
Correspondent
Emde Corp.
The Liberty Center
350 S. Center St., Suite 340
Reno,  NV  89501
Correspondent Contact MICHAEL H SNYDER
Regulation Number876.5980
Classification Product Code
KNT  
Date Received01/06/1986
Decision Date 02/06/1986
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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