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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Marker, Colon
510(k) Number K993951
Device Name SPOT ENDOSCOPIC MARKER
Applicant
Chek-Med Systems
11 Phelps Way
P.O. Box 289
Willington,  CT  06279
Applicant Contact ROB WHALEN
Correspondent
Chek-Med Systems
11 Phelps Way
P.O. Box 289
Willington,  CT  06279
Correspondent Contact ROB WHALEN
Regulation Number876.1500
Classification Product Code
NBG  
Date Received11/22/1999
Decision Date 02/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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