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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 K853980
Device Name EROSA DISPOSABLE HYPODERMIC NEEDLE
Applicant
Rose KG
One Farragut Sq. S.
Washington,  DC  20006
Applicant Contact LOTHAR GRIESSBACH
Correspondent
Rose KG
One Farragut Sq. S.
Washington,  DC  20006
Correspondent Contact LOTHAR GRIESSBACH
Regulation Number878.4800
Classification Product Code
GAA  
Date Received09/27/1985
Decision Date 10/18/1985
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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