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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name General Surgery Tray
510(k) Number K935858
Device Name MILL-ROSE PERCUTANEOUS PROCEDURAL KIT
Applicant
Mill-Rose Laboratory
7310 Corporate Blvd.
Mentor,  OH  44060
Applicant Contact ALAN C POJE
Correspondent
Mill-Rose Laboratory
7310 Corporate Blvd.
Mentor,  OH  44060
Correspondent Contact ALAN C POJE
Regulation Number878.4370
Classification Product Code
LRO  
Date Received12/08/1993
Decision Date 02/22/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
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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