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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 K830719
Device Name UNIVERSAL CANNULA
Applicant
Acufex Microsurgical, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Acufex Microsurgical, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/08/1983
Decision Date 06/16/1983
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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