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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Trocar, Gastro-Urology
510(k) Number K841716
Device Name ENDOPORT EROCAR
Applicant
Endotherapeutics
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Endotherapeutics
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.5090
Classification Product Code
FBQ  
Date Received04/25/1984
Decision Date 06/28/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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