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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Aspiration And Injection, Disposable
510(k) Number K894326
Device Name THORACENTISIS KIT
Applicant
Mill-Rose Laboratory
7310 Corporate Blvd.
Mentor,  OH  44060
Applicant Contact MARK KOZAK
Correspondent
Mill-Rose Laboratory
7310 Corporate Blvd.
Mentor,  OH  44060
Correspondent Contact MARK KOZAK
Regulation Number878.4800
Classification Product Code
GAA  
Date Received07/14/1989
Decision Date 07/24/1989
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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