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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
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