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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K852104
Device Name MANAN PTC BIOPSY TRAYS
Applicant
Manan Manufacturing Co., Inc.
8020 N. Central Park Ave.
Skokie,  IL  60076
Applicant Contact MANFRED MITTERMEIR
Correspondent
Manan Manufacturing Co., Inc.
8020 N. Central Park Ave.
Skokie,  IL  60076
Correspondent Contact MANFRED MITTERMEIR
Date Received05/15/1985
Decision Date 06/19/1985
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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