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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Surgical, General & Plastic Surgery
510(k) Number K833377
Device Name MEDICALEX
Applicant
Medicalex
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Medicalex
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4800
Classification Product Code
GEA  
Date Received09/29/1983
Decision Date 09/27/1984
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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