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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 K983428
Device Name SAFETEX CERVICAL SCRAPER (PLASTIC)
Applicant
ANDWIN SCIENTIFIC
6636 VARIEL AVE.
CANOGA PARK,  CA  91303
Applicant Contact NATALIE SARRAF
Correspondent
ANDWIN SCIENTIFIC
6636 VARIEL AVE.
CANOGA PARK,  CA  91303
Correspondent Contact NATALIE SARRAF
Regulation Number884.4530
Classification Product Code
HHT  
Date Received09/29/1998
Decision Date 11/16/1998
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
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