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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 K983599
Device Name SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT
Applicant
Andwin Scientific
6636 Variel Ave.
Woodland Hills,  CA  91303
Applicant Contact NATALIE SARRAF
Correspondent
Andwin Scientific
6636 Variel Ave.
Woodland Hills,  CA  91303
Correspondent Contact NATALIE SARRAF
Regulation Number884.4530
Classification Product Code
HHT  
Subsequent Product Code
LIO  
Date Received10/14/1998
Decision Date 12/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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