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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name table, cystometric, non-electric and accessories
510(k) Number K760522
Device Name TABLE, UROSURGICAL
Applicant
MALLINCKRODT GROUP, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MALLINCKRODT GROUP, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.4890
Classification Product Code
KQS  
Date Received08/26/1976
Decision Date 12/16/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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