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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K023261
Device Name ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244
Applicant
Taut, Inc.
2571 Kaneville Ct.
Geneva,  IL  60134
Applicant Contact MAX CLOAT
Correspondent
Taut, Inc.
2571 Kaneville Ct.
Geneva,  IL  60134
Correspondent Contact MAX CLOAT
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/30/2002
Decision Date 12/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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