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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 K832986
Device Name PAP SMEAR BRUSH
Applicant
DONALD G. ZELLER
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
DONALD G. ZELLER
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number884.4530
Classification Product Code
HHT  
Date Received09/01/1983
Decision Date 02/10/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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