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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Bite Block
510(k) Number K924764
Device Name OVERTUBE FOR ENDSCOPIC LIGATOR
Applicant
Superior Healthcare Group, Inc.
Cumberland Industrial Park
Cumberland,  RI  02864
Applicant Contact MAUREEN G MCCABE
Correspondent
Superior Healthcare Group, Inc.
Cumberland Industrial Park
Cumberland,  RI  02864
Correspondent Contact MAUREEN G MCCABE
Regulation Number876.1500
Classification Product Code
MNK  
Subsequent Product Code
FED  
Date Received09/23/1992
Decision Date 03/15/1993
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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