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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 K991593
Device Name ORIBRUSH - STANDARD - B002
Applicant
Orifice Medical AB
Bronsgatan 12
Ystad,  SE S-271 39
Applicant Contact PATRIK NILSSON
Correspondent
Orifice Medical AB
Bronsgatan 12
Ystad,  SE S-271 39
Correspondent Contact PATRIK NILSSON
Regulation Number884.4530
Classification Product Code
HHT  
Date Received05/07/1999
Decision Date 06/29/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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