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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 K111681
Device Name HISTOBRUSH
Applicant
PURITAN MEDICAL PRODUCTS COMPANY LLC
31 SCHOOL ST.
GUILFORD,  ME  04443
Applicant Contact WILLIAM M YOUNG
Correspondent
PURITAN MEDICAL PRODUCTS COMPANY LLC
31 SCHOOL ST.
GUILFORD,  ME  04443
Correspondent Contact WILLIAM M YOUNG
Regulation Number884.4530
Classification Product Code
HHT  
Date Received06/15/2011
Decision Date 01/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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