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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, abortion, vacuum
510(k) Number K813282
Device Name SYNEVAC VACUUM CURETTAGE SYSTEMS
Applicant
SYNEMED, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
SYNEMED, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number884.5070
Classification Product Code
HHI  
Date Received11/17/1981
Decision Date 12/14/1981
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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