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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 K042527
Device Name SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107
Applicant
MEDICAL ACTION INDUSTRIES, INC.
25 HEYWOOD RD.
ARDEN,  NC  28704
Applicant Contact ROBIN BLANKENBAKER
Correspondent
MEDICAL ACTION INDUSTRIES, INC.
25 HEYWOOD RD.
ARDEN,  NC  28704
Correspondent Contact ROBIN BLANKENBAKER
Regulation Number884.4530
Classification Product Code
HHT  
Date Received09/17/2004
Decision Date 11/08/2004
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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