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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spatula, Cervical, Cytological
510(k) Number K902591
Device Name CYTETTE(TM) CYTOLOGY BRUSH
Applicant
Birchwood Laboratories, Inc.
7900 Fuller Rd.
Eden Prairie,  MN  55344
Applicant Contact MICHAEL D LENARZ
Correspondent
Birchwood Laboratories, Inc.
7900 Fuller Rd.
Eden Prairie,  MN  55344
Correspondent Contact MICHAEL D LENARZ
Regulation Number884.4530
Classification Product Code
HHT  
Date Received06/12/1990
Decision Date 09/10/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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