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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 K002520
Device Name ROVERS SPATULA
Applicant
ROVERS MEDICAL DEVICES B.V.
960 CHAPEA RD.
PASADENA,  CA  91107
Applicant Contact TODD M GATES
Correspondent
ROVERS MEDICAL DEVICES B.V.
960 CHAPEA RD.
PASADENA,  CA  91107
Correspondent Contact TODD M GATES
Regulation Number884.4530
Classification Product Code
HHT  
Date Received08/15/2000
Decision Date 11/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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