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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
510(k) Number K972112
Device Name INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450
Applicant
Taut, Inc.
2571 Kaneville Ct.
P.O. Box 326
Geneva,  IL  60134
Applicant Contact GLENN MILLER
Correspondent
Taut, Inc.
2571 Kaneville Ct.
P.O. Box 326
Geneva,  IL  60134
Correspondent Contact GLENN MILLER
Regulation Number878.4200
Classification Product Code
GBW  
Date Received06/05/1997
Decision Date 12/01/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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