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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K851701
Device Name MANAN ZAVALA NEEDLE
Applicant
Manan Manufacturing Co., Inc.
8020 N. Central Park Ave.
Skokie,  IL  60076
Applicant Contact MANFRED MITTERMEIER
Correspondent
Manan Manufacturing Co., Inc.
8020 N. Central Park Ave.
Skokie,  IL  60076
Correspondent Contact MANFRED MITTERMEIER
Date Received04/24/1985
Decision Date 05/14/1985
Decision Substantially Equivalent (SESE)
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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