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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Catheter
510(k) Number K842666
Device Name NU-THOR THORACOSTOMY KIT
Applicant
Intl. Medical Devices , Ltd.
530 Seco Rd.
Monroeville,  PA  15146
Correspondent
Intl. Medical Devices , Ltd.
530 Seco Rd.
Monroeville,  PA  15146
Regulation Number878.4200
Classification Product Code
KGZ  
Date Received07/10/1984
Decision Date 09/20/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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