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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 -4885
Applicant Contact MARK KOZAK
Correspondent
MILL-ROSE LABORATORY
7310 CORPORATE BLVD.
MENTOR,  OH  44060 -4885
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
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