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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cap, cervical
510(k) Number K810697
Device Name AXISONIC II
Applicant
TEKNAR, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
TEKNAR, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number884.5250
Classification Product Code
HDR  
Date Received03/16/1981
Decision Date 07/13/1981
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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