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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Peritoneal, Long-Term Indwelling
510(k) Number K120130
Device Name FALLER TROCAR
Applicant
Medigroup, Inc.
14 A Stonehill Rd.
Oswego,  IL  60543
Applicant Contact IRENE NAVIS
Correspondent
Medigroup, Inc.
14 A Stonehill Rd.
Oswego,  IL  60543
Correspondent Contact IRENE NAVIS
Regulation Number876.5630
Classification Product Code
FJS  
Date Received01/17/2012
Decision Date 05/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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