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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, abortion, vacuum
510(k) Number K983181
Device Name CYTOPREP
Applicant
CYTOPREP INC. EST.
RENKWILER 593
ESCHEN,  LI 9492
Applicant Contact K G PAGANIS
Correspondent
CYTOPREP INC. EST.
RENKWILER 593
ESCHEN,  LI 9492
Correspondent Contact K G PAGANIS
Regulation Number884.5070
Classification Product Code
HHI  
Date Received09/11/1998
Decision Date 11/16/1998
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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