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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aspirator, Endocervical
510(k) Number K801238
Device Name ACCU-PAP T ZONE SAMPLER
Applicant
Robert Hasselbrack, M.D.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Robert Hasselbrack, M.D.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number884.1050
Classification Product Code
HFC  
Date Received05/27/1980
Decision Date 08/12/1980
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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